Agency Information Collection Activities: Submission for OMB Review; Comment Request, 16217-16218 [E9-8141]

Download as PDF Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices dwashington3 on PROD1PC60 with NOTICES only upon valid scientific evidence to determine whether there is reasonable assurance of the safety and effectiveness of the device, if regulated by general controls alone (class I) or by general controls and special controls (class II). Valid scientific evidence consists of evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, welldocumented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. The evidence required may vary according to the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use. Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness (see § 860.7(c)(2)). According to § 860.7(d)(1), there is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks. The valid scientific evidence used to determine the safety of a device shall adequately demonstrate the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions for use. Moreover, under § 860.7(e)(1), there is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results. IV. Submission of Required Information The summary of, and citation to, any information required by the act must be submitted by the dates listed in the DATES section of this document to the Division of Dockets Management (see ADDRESSES). VerDate Nov<24>2008 15:28 Apr 08, 2009 Jkt 217001 V. Paperwork Reduction Act of 1995 This order refers to collections of information necessary to comply with the requirements found in sections 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807, subpart E or the requirements of 515(b) of the act (21 U.S.C. 360e(b)), 21 CFR part 860, and 21 CFR part 814. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 860.123 have been approved under OMB control number 0910–0138; the collections of information in 21 CFR part 814, have been approved under OMB control number 0910–0231; and the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120. Dated: April 2, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–8022 Filed 4–8–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] The 12th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference; ‘‘Regulatory Affairs: The Challenges of Ensuring Product Safety’’ AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration (FDA) is announcing the following conference: 12th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive questions and answers, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 16217 Date and Time: The conference will be held on June 9 and 10, 2009, from 7:30 a.m. to 5 p.m. Location: The conference will be held at the Irvine Marriott Hotel, 18000 Von Karman Ave., Irvine, CA 92612. Contact: Linda Hartley, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949–608–4413, FAX: 949–608–4417, or OCRA, Attention to Detail, 5319 University Dr., suite 641, Irvine, CA 92612, 949–387–9046, FAX: 949–387–9047, Web site: http:// www.ocra-dg.org. Registration and Meeting Information: See OCRA Web site, http://www.ocradg.org. Contact Attention to Detail at 949–387–9046. Before May 8, 2009, registration fees are as follows: $675.00 for members, $725.00 for nonmembers and $475.00 for FDA/Govt/Students.1 After May 8, 2009, $725.00 for members, $775.00 for nonmembers, and $475.00 for FDA/ Govt/Students.1 The registration fee will cover actual expenses including refreshments, lunch, materials, parking, and speaker expenses. If you need special accommodations due to a disability, please contact Linda Hartley at least 10 days in advance. Dated: April 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–8135 Filed 4–8–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management 1 OCRA Student Rate applies to those individuals enrolled in a Regulatory or Quality related academic program at an accredited institution. Proof of enrollment required. E:\FR\FM\09APN1.SGM 09APN1 16218 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Uncompensated Services Assurance Report (OMB No. 0915–0077)—[Extension] Under the Hill-Burton Act, the government provides grants and loans for construction or renovation of health care facilities. As a condition of receiving this construction assistance, facilities are required to provide services to persons unable to pay. A condition of receiving this assistance requires facilities to provide assurances periodically that the required level of Responses per respondent Number of respondents Instrument uncompensated care is being provided, and that certain notification and record keeping procedures are being followed. These requirements are referred to as the uncompensated services assurance. The annual estimate of burden is as follows: Total responses Hours per response Total burden hours Disclosure Burden (42 CFR) Published Notices (124.504(c)) ........................................... Individual Notices (124.504(c)) ............................................ Determinations of Eligibility (124.507) ................................. 86 86 86 1 1 99 86 86 8,514 0.75 43.6 0.75 64.5 3,749.6 6,385.50 Subtotal disclosure burden ........................................... ........................ ........................ ........................ ........................ 10,199.60 10 1 10 11.0 110 4 0 2 1 ........................ 1 4 ........................ 2 6.0 ........................ 6.0 24 ........................ 12 37 14 0 1 1 1 37 14 0 0.5 0.5 0.5 18.5 7 0 10 10 ........................ 1 1 ........................ 10 10 ........................ 0.25 0.5 ........................ 2.5 5 179 Number of recordkeepers Hours per year Non-alternative Facilities (124.510(a)) ........................................................................................ 86 50 4,300 Subtotal recordkeeping burden ............................................................................................ ........................ ........................ 4,300 Reporting Uncompensated Services Report—HRSA–710 Form (124.509(a)) ...................................................................... Application for Compliance Alternatives: Public Facilities (124.513) ............................................ Small Obligation Facilities (124.514(c)) ........................ Charitable Facilities (124.516(c)) .................................. Annual Certification for Compliance Alternatives: Public Facilities (124.509(b)) ........................................ Charitable Facilities (124.509(b)) ................................. Small Obligation Facilities (124.509(c)) ........................ Complaint Information (124.511(a)): Individuals ..................................................................... Facilities ........................................................................ Subtotal reporting burden ............................................. Recordkeeping The total burden for this project is estimated to be 14,678.60 hours. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to (202) 395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: April 3, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–8141 Filed 4–8–09; 8:45 am] dwashington3 on PROD1PC60 with NOTICES BILLING CODE 4165–15–P VerDate Nov<24>2008 15:28 Apr 08, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC); 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 Heritable Disorders in Newborns and Children. Date and Time: May 12, 2009, 1 p.m.–5 p.m. EST. Place: Web cast. The ACHDNC will meet on Tuesday, May 12, 2009 from 1 p.m. to 5 p.m. EST. The general public can join the meeting via Webcast by logging onto http:// altarum.na3.acrobat.com/achdnc/; next select ‘‘enter as a guest,’’ type in your full name, and click ‘‘enter room.’’ Participants must also dial the toll free phone number for audio (listen only). The dial-in number is 1 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Total hour burden (877) 551–8166; when prompted say the password ‘‘HRSA Genetics’’. Participants should call no later than 12:50 p.m. EST in order for the logistics to be established for participation in the call. If there are technical problems gaining access to the call, please contact Alison Gary, Web Meetings Coordinator, Altarum Institute, telephone (202) 828–5100, or e-mail webmeeting@altarum.org. Meeting Registration: General public participants are asked to register for the conference by going to the meeting Web site at http://events.SignUp4.com/achdnc0509. The registration deadline is Monday, May 11, 2009. Special Accommodations: Attendees requiring special needs such as large print materials or additional special needs may make comments when registering at the Online Web site. Or you may wish to contact Tamar R. Shealy, Senior Meetings Manager, Conference and Meetings Management, Conference, Web and Communication Services, Altarum Institute; telephone (202) 828–5100, or e-mail Tamar Shealy at conferences@altarum.org. Agenda: The meeting will include (1) A presentation of the external review E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 74, Number 67 (Thursday, April 9, 2009)]
[Notices]
[Pages 16217-16218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, e-mail 
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 
443-1129.
    The following request has been submitted to the Office of 
Management

[[Page 16218]]

and Budget for review under the Paperwork Reduction Act of 1995:

Proposed Project: Uncompensated Services Assurance Report (OMB No. 
0915-0077)--[Extension]

    Under the Hill-Burton Act, the government provides grants and loans 
for construction or renovation of health care facilities. As a 
condition of receiving this construction assistance, facilities are 
required to provide services to persons unable to pay. A condition of 
receiving this assistance requires facilities to provide assurances 
periodically that the required level of uncompensated care is being 
provided, and that certain notification and record keeping procedures 
are being followed. These requirements are referred to as the 
uncompensated services assurance.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
           Instrument               respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
                                           Disclosure Burden (42 CFR)
----------------------------------------------------------------------------------------------------------------
Published Notices (124.504(c))..              86               1              86            0.75            64.5
Individual Notices (124.504(c)).              86               1              86            43.6         3,749.6
Determinations of Eligibility                 86              99           8,514            0.75        6,385.50
 (124.507)......................
                                 -------------------------------------------------------------------------------
    Subtotal disclosure burden..  ..............  ..............  ..............  ..............       10,199.60
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
Uncompensated Services Report--               10               1              10            11.0             110
 HRSA-710 Form (124.509(a)).....
Application for Compliance
 Alternatives:
    Public Facilities (124.513).               4               1               4             6.0              24
    Small Obligation Facilities                0  ..............  ..............  ..............  ..............
     (124.514(c))...............
    Charitable Facilities                      2               1               2             6.0              12
     (124.516(c))...............
Annual Certification for
 Compliance Alternatives:
    Public Facilities                         37               1              37             0.5            18.5
     (124.509(b))...............
    Charitable Facilities                     14               1              14             0.5               7
     (124.509(b))...............
    Small Obligation Facilities                0               1               0             0.5               0
     (124.509(c))...............
Complaint Information
 (124.511(a)):
    Individuals.................              10               1              10            0.25             2.5
    Facilities..................              10               1              10             0.5               5
    Subtotal reporting burden...  ..............  ..............  ..............  ..............             179
----------------------------------------------------------------------------------------------------------------


 
                                                                     Number of                      Total hour
                          Recordkeeping                            recordkeepers  Hours per year      burden
----------------------------------------------------------------------------------------------------------------
Non-alternative Facilities (124.510(a)).........................              86              50           4,300
                                                                 -----------------------------------------------
    Subtotal recordkeeping burden...............................  ..............  ..............           4,300
----------------------------------------------------------------------------------------------------------------

    The total burden for this project is estimated to be 14,678.60 
hours. Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to (202) 395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: April 3, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-8141 Filed 4-8-09; 8:45 am]
BILLING CODE 4165-15-P