Agency Information Collection Activities: Proposed Collection: Comment Request, 37084-37085 [E6-10236]

Download as PDF 37084 Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0191] The Use of Bayesian Statistics in Medical Device Clinical Trials; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing the following public meeting: The Use of Bayesian Statistics in Medical Device Clinical Trials. The draft guidance entitled ‘‘Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials’’ provides FDA’s recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. DATES: The public meeting will be held on July 27, 2006, from 8:30 a.m. to 5 p.m. Registration for this meeting is required (see the Registration section of this document for details). Submit written or electronic comments on the draft guidance by August 21, 2006. ADDRESSES: The public meeting will be held at The Universities at Shady Grove, 9630 Gudelsky Dr., Rockville, MD. Additional information about and directions to the facility are available on the Internet at http://www.fda.gov/cdrh/ meetings/072706-bayesian.html. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Cindy Garris, Center for Devices and Radiological Health (HFZ–220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276– 3150, ext. 121, FAX: 240–276–3151, email: Cynthia.garris@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: jlentini on PROD1PC65 with NOTICES I. Background Bayesian statistics is a theory and approach to data analysis that provides a coherent method for learning from evidence as evidence accumulates. In situations where good information on clinical use of a device already exists, the Bayesian approach may enable FDA to reach the same decision on a device VerDate Aug<31>2005 17:03 Jun 28, 2006 Jkt 208001 with a smaller-sized or shorter-duration pivotal trial. In other instances, a Bayesian approach can provide flexible methods for handling interim analyses and other modifications to trials. The draft guidance entitled ‘‘Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials’’ describes FDA’s current thinking on statistical aspects of the design and analysis of medical device clinical trials that use Bayesian statistical methods. FDA announced the availability of the draft guidance on May 23, 2006 (71 FR 29651). The draft guidance is available at http:// www.fda.gov/cdrh/osb/guidance/ 1601.html. II. Agenda FDA will provide presentations on the draft guidance entitled ‘‘Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials’’ in the morning. In the afternoon, panels will discuss the draft guidance. There will be opportunities for public participation throughout the day. III. Registration Online registration for the meeting is required. Acceptance will be on a firstregistered, first-served basis. There are no assurances of onsite registration. Please register online at http:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfsud/bayesian_meeting.cfm. FDA is pleased to provide the opportunity for interested persons to listen from a remote location to the live proceedings of the meeting. In order to ensure that a sufficient number of callin lines are available, please register to listen to the meeting at http:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfsud/bayesian_meeting.cfm by July 21, 2006. Persons without Internet access may call 240–276–3150, ext. 121, by July 21, 2006, to register for onsite meeting attendance or to register to listen to the meeting by phone. If you need special accommodations due to a disability, please contact Cindy Garris (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. IV. Request for Input and Materials FDA is interested in receiving input from stakeholders on the draft guidance. Send suggestions or recommendations to the Division of Dockets Management (see ADDRESSES). FDA will place an additional copy of any material it receives on the docket (Docket No. 2006D–0191). Suggestions, recommendations, and materials may be seen at the Division of Dockets Management (see ADDRESSES) between 9 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 a.m. and 4 p.m., Monday through Friday. V. Transcripts Following the meeting, transcripts will be available for review at the Division of Dockets Management (see ADDRESSES). Dated: June 23, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–5804 Filed 6–26–06; 12:30 pm] BILLING CODE 4160–01–S 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 through the use of automated collection techniques or other forms of information technology. Proposed Project: The Health Education Assistance Loan (HEAL) Program: Forms (OMB No. 0915–0043)— Extension The Health Education Assistance Loan (HEAL) program continues to administer and monitor outstanding loans which were provided to eligible students to pay for educational costs in E:\FR\FM\29JNN1.SGM 29JNN1 37085 Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices a number of health professions. HEAL forms collect information that is required for responsible program management. The HEAL Repayment Schedule, Fixed and Variable, provides the borrower with the cost of a HEAL loan, the number and amount of payments, and the Truth-in-Lending disclosures. The Lender’s Report on HEAL Student Loans Outstanding (Call Report) provides information on the status of loans outstanding by the number of borrowers and total number of loans whose loan payments are in various stages of the loan cycle, such as student education and repayment, and Number of respondents Form Responses per respondent the corresponding dollar amounts. These forms are needed to provide borrowers with information on the cost of their loan(s) and to determine which lenders may have excessive delinquencies and defaulted loans. The estimate of burden for the forms is as follows: Total responses Hours per response Total burden hours Repayment Schedule HRSA 502 ........................................ Call Report HRSA–512 ........................................................ 8 20 666 4 5,328 80 .5 .75 2,664 60 Total .............................................................................. 28 ........................ 5,408 ........................ 2,724 Send comments to Susan G. Queen, Ph.D., 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: June 22, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6–10236 Filed 6–28–06; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration ‘‘Low Income Levels’’ Used for Various Health Professions and Nursing Programs Included in Titles III, VII and VIII of the Public Health Service Act Health Resources and Services Administration, HHS. ACTION: Notice. jlentini on PROD1PC65 with NOTICES AGENCY: SUMMARY: The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ‘‘low income family’’ for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII and VIII of the Public Health Service (PHS) Act. The Department periodically publishes in the Federal Register low income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ‘‘low income families.’’ VerDate Aug<31>2005 17:03 Jun 28, 2006 Jkt 208001 The various health professions and nursing grant and cooperative agreement programs that use the low-income levels to determine whether an individual is from an economically disadvantaged background in making eligibility and funding determinations generally make awards to: Accredited schools of medicine, osteopathic medicine, public health, dentistry, veterinary medicine, optometry, pharmacy, allied health podiatric medicine, nursing, chiropractic, public or private nonprofit schools which offer graduate programs in behavioral health and mental health practice, and other public or private nonprofit health or education entities to assist the disadvantaged to enter and graduate from health professions and nursing schools. Some programs provide for the repayment of health professions or nursing education loans for disadvantaged students. poverty guidelines are based on poverty thresholds published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index. The Secretary annually adjusts the low income levels based on the Department’s poverty guidelines and makes them available to persons responsible for administering the applicable programs. The income figures below have been updated to reflect increases in the Consumer Price Index through December 31, 2005. Low-Income Levels The Secretary defines a ‘‘low income family’’ for programs included in Titles III, VII and VIII of the PHS Act as having an annual income that does not exceed 200 percent of the Department’s poverty guidelines. A family is a group of two or more individuals related by birth, marriage, or adoption who live together or an individual who is not living with any relatives. Most HRSA programs use the income of the student’s parents to compute low income status, while a few programs, depending upon the legislative intent of the program, programmatic purpose of the low income level, as well as the age and circumstances of the average participant, will use the student’s family as long as he or she is not listed as a dependent upon the parents’ tax form. Each program will announce the rationale and choice of methodology for determining low income levels in their program guidance. The Department’s * Includes only dependents listed on Federal income tax forms. Some programs will use the student’s family rather than his or her parents’ family. ** Adjusted gross income for calendar year 2005. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Size of parents’ family * 1 2 3 4 5 6 7 8 .................................................. .................................................. .................................................. .................................................. .................................................. .................................................. .................................................. .................................................. Income Level ** $19,600 26,400 33,200 40,000 46,800 53,600 60,400 67,200 Dated: June 21, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6–10238 Filed 6–28–06; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HOMELAND SECURITY Agency Information Collection Activities: New Information Collection, Comment Request 60-Day Notice of Information Collection Under Review: CIS Ombudsman Case Problem Submission, Form G–1107. OMB Control No. 1615– NEW. ACTION: E:\FR\FM\29JNN1.SGM 29JNN1

Agencies

[Federal Register Volume 71, Number 125 (Thursday, June 29, 2006)]
[Notices]
[Pages 37084-37085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10236]


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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 through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: The Health Education Assistance Loan (HEAL) Program: 
Forms (OMB No. 0915-0043)--Extension

    The Health Education Assistance Loan (HEAL) program continues to 
administer and monitor outstanding loans which were provided to 
eligible students to pay for educational costs in

[[Page 37085]]

a number of health professions. HEAL forms collect information that is 
required for responsible program management. The HEAL Repayment 
Schedule, Fixed and Variable, provides the borrower with the cost of a 
HEAL loan, the number and amount of payments, and the Truth-in-Lending 
disclosures. The Lender's Report on HEAL Student Loans Outstanding 
(Call Report) provides information on the status of loans outstanding 
by the number of borrowers and total number of loans whose loan 
payments are in various stages of the loan cycle, such as student 
education and repayment, and the corresponding dollar amounts. These 
forms are needed to provide borrowers with information on the cost of 
their loan(s) and to determine which lenders may have excessive 
delinquencies and defaulted loans.
    The estimate of burden for the forms is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Repayment Schedule HRSA 502.....               8             666           5,328              .5           2,664
Call Report HRSA-512............              20               4              80             .75              60
                                 -------------------------------------------------------------------------------
    Total.......................              28  ..............           5,408  ..............           2,724
----------------------------------------------------------------------------------------------------------------

    Send comments to Susan G. Queen, Ph.D., 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: June 22, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
 [FR Doc. E6-10236 Filed 6-28-06; 8:45 am]
BILLING CODE 4165-15-P