Agency Information Collection Activities: Proposed Collection: Comment Request, 13806-13807 [E7-5293]

Download as PDF 13806 Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices participate in a meeting when statutory criteria are met; for example, when the need for the individual’s services outweighs the potential for a conflict of interest created by the financial interest involved. FDA administers several laws and regulations that govern conflict of interest determinations; these laws are not entirely consistent and set out different standards. FDA’s Waiver Criteria 2000 guidance, which this draft guidance would replace, attempted to comprehensively address the complex set of variables that can be applied in reaching a determination about an individual advisory committee participant. However, because of its complexity and discretionary elements, FDA staff found it difficult to achieve consistent results that the public could readily understand. As part of FDA’s recent internal assessment of its advisory committee process, the agency has targeted its assessment of potential conflicts of interest and granting of waivers as an area that needs improvement. This draft guidance will implement a more stringent approach for considering eligibility for participation in FDA advisory committee meetings. The purpose of this draft guidance is to simplify and streamline the process by which FDA considers meeting participation, increase the transparency, clarity, and consistency of the process, and enhance public trust in this important function. We welcome comments on the draft guidance and specifically seek comment on (1) whether the draft approach, due to its stringency, could unduly restrict eligibility of needed experts for advisory committee meetings, (2) whether the $50,000 figure generally employed as the maximum amount for disqualifying financial interests, after applying certain exemptions, is appropriate or, alternatively, whether a different figure (higher or lower) should be used, and (3) whether and what additional examples should be provided for the steps described in this draft guidance for determining conflicts of interest and eligibility for participating in an advisory committee meeting. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance represents the agency’s current thinking on procedures for considering conflict of interest and eligibility for participation in FDA advisory committees. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. III. Electronic Access Persons with access to the Internet may obtain the document at: http:// www.fda.gov/opacom/morechoices/ industry/guidedc.htm sroberts on PROD1PC70 with NOTICES Proposed Project: The National Health Service Corps (NHSC) Scholarship Program In-School Worksheets (OMB No. 0915–0250): Extension Dated: March 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07–1459 Filed 3–21–07; 1:43 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. Number of respondents Instrument 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. Responses per respondent The National Health Service Corps (NHSC) Scholarship program provides scholarships to students in health professions in return for service in a federally-designated Health Professional Shortage Area (HPSA). If awarded an NHSC scholarship, the program requires the schools and the awardees to review and complete data collection worksheets for each year that the student is an NHSC Scholar. The forms provide information on the following: Verification of enrollment status; current curriculum; current contact information; and verification of accuracy of student data. The worksheets require minimal burden and provide the program with information that is required to determine if scholars are maintaining their status of eligibility as required by Federal statute. The annual estimate of burden is as follows: Hours per response (minutes) Total responses Total burden hours Scholar Worksheet ............................................................... School Verification Worksheet ............................................. School Contact Information ................................................. 800 300 550 1 1 1 800 300 550 10 10 10 134 50 92 Total .............................................................................. 1,650 ........................ 1,650 ........................ 276 VerDate Aug<31>2005 17:56 Mar 22, 2007 Jkt 211001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1 Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices Health Resources and Services Administration Proposed agenda items are subject to change. Time will be provided each day for public comment. Individuals who wish to provide public comment or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the ACHDGDNC Staff, Jill F. Shuger, M.S. (contact information provided below). Contact Person: Anyone interested in obtaining a roster of members or other relevant information should write or contact Jill F. Shuger, M.S., Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–1080. Information on the Advisory Committee is available at http:// mchb.hrsa.gov/programs/genetics/committee. Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children; Notice of Meeting Dated: March 15, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–5300 Filed 3–22–07; 8:45 am] 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: March 15, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–5293 Filed 3–22–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES sroberts on PROD1PC70 with NOTICES 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 Heritable Disorders and Genetic Diseases in Newborns and Children (ACHDGDNC). Dates and Times: May 17, 2007, 9 a.m. to 5 p.m. May 18, 2007, 8:30 a.m. to 3 p.m. Place: Ronald Reagan Building and International Trade Center, Rotunda Room, 1300 Pennsylvania Avenue, NW., Washington, DC 20004. Status: The meeting will be open to the public with attendance limited to space availability. Purpose: The Advisory Committee was established to advise and guide the Secretary regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines and programs for effectively reducing morbidity and mortality in newborns and children having or at risk for heritable disorders. The Committee also provides advice and recommendations concerning the grants and projects authorized under the Heritable Disorders Program. Agenda: The first day will be devoted to discussion of the Committee’s decisionmaking process, including a discussion of the evidence review group’s nomination/evaluation process for candidate conditions on the uniform newborn screening panel, and an evaluation of the system infrastructure for long-term follow-up and proposals for strategies for such followup. The Committee’s subcommittees on Laboratory Standards and Procedures, Follow-up and Treatment, and Education and Training will meet in the afternoon. The second day will include a report from the Department of Defense on its newborn screening program and activities and reports to the Committee by its subcommittees on Laboratory Standards and Procedures, Follow-up and Treatment, and Education and Training. VerDate Aug<31>2005 16:41 Mar 22, 2007 Jkt 211001 BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Nurse Education and Practice; 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: National Advisory Council on Nurse Education and Practice (NACNEP). Dates and Times: April 19, 2007, 9 a.m.— 5 p.m. April 20, 2007, 8 a.m.–5 p.m. Place: Hotel Washington, 515 15th Street, NW., Washington, DC 20004. Status: The meeting will be open to the public. Agenda: Agency and Bureau administrative updates will be provided. The purpose of the meeting will be to discuss the integration of health information technology into nursing education and practice. Experts will promote the awareness of the latest simulated learning, informatics, distance learning, and telehealth trends, advances, and issues. Data will be presented on use of healthcare information systems to enhance nursing education and practice, optimize patient safety, and drive improvements in health care quality. Representatives from the Department of Health and Human Services, the National Center for Cultural Competence, and the National Nursing Centers Consortium will be presenting. During this meeting, Council workgroups will deliberate on the content presented and formulate recommendations to the Secretary of Health and Human Services and the Congress on the integration of technology into nursing education and practice. This meeting will PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 13807 form the basis for NACNEP’s mandated Eighth Annual Report. For Further Information Contact: Anyone interested in obtaining a roster of members, minutes of the meeting, or other relevant information should write or contact Dr. Joan Weiss, Executive Secretary, National Advisory Council on Nurse Education and Practice, Parklawn Building, Room 9–35, 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 443–5688. Dated: March 15. 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–5295 Filed 3–22–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Final Policy Guidance Health Resources and Services Administration (HRSA), HHS. ACTION: Final Agency Guidance and Response to Public Comments. AGENCY: SUMMARY: HRSA is publishing a final Agency Guidance (‘‘Policy Information Notice’’ (PIN) 2007–09) to describe and clarify HRSA’s current policy and process for resolving issues and conflicts related to health center service area overlap. The PIN, ‘‘Service Area Overlap: Policy and Process,’’ and the Agency’s ‘‘Response to Public Comments’’ are available on the Internet at http://bphc.hrsa.gov/chc/sao.htm. DATES: The effective date of this final Agency guidance is March 12, 2007. Background: HRSA manages the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver preventive and primary care services to patients regardless of their ability to pay. Charges for health care services are set according to income. On June 22, 2006, HRSA made the draft PIN, ‘‘Service Area Overlap: Policy and Process,’’ available for public comment on HRSA’s Web site. The purpose of the PIN is to describe and clarify HRSA’s current policy and process for resolving issues and conflicts related to health center service area overlap. Comments were due to HRSA by August 18, 2006. E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 72, Number 56 (Friday, March 23, 2007)]
[Notices]
[Pages 13806-13807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5293]


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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 National Health Service Corps (NHSC) Scholarship 
Program In-School Worksheets (OMB No. 0915-0250): Extension

    The National Health Service Corps (NHSC) Scholarship program 
provides scholarships to students in health professions in return for 
service in a federally-designated Health Professional Shortage Area 
(HPSA). If awarded an NHSC scholarship, the program requires the 
schools and the awardees to review and complete data collection 
worksheets for each year that the student is an NHSC Scholar. The forms 
provide information on the following: Verification of enrollment 
status; current curriculum; current contact information; and 
verification of accuracy of student data. The worksheets require 
minimal burden and provide the program with information that is 
required to determine if scholars are maintaining their status of 
eligibility as required by Federal statute.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                                                     Hours per
           Instrument                Number of     Responses per       Total         response      Total burden
                                    respondents     respondent       responses       (minutes)         hours
----------------------------------------------------------------------------------------------------------------
Scholar Worksheet...............             800               1             800              10             134
School Verification Worksheet...             300               1             300              10              50
School Contact Information......             550               1             550              10              92
                                 -------------------------------------------------------------------------------
    Total.......................           1,650  ..............           1,650  ..............             276
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[[Page 13807]]

    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: March 15, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-5293 Filed 3-22-07; 8:45 am]
BILLING CODE 4165-15-P