Agency Information Collection Activities: Proposed Collection Comment Request, 5444-5445 [E7-1824]

Download as PDF 5444 Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices guidance documents on quality systems auditing practices. As a result of its efforts, this group has developed document SG4(PD)N33R13:2006. SG4(PD)N33R13:2006 (proposed document), entitled ‘‘Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers—Part 3: Regulatory Audit Reports,’’ suggests a structure for audit reports used in multiple jurisdictions, promoting consistency and uniformity and should assist the auditor in preparing a report for use by multiple regulators and/or auditing organizations. Having reports that are consistent in content should facilitate the review and exchange of audit reports. Acceptance of audit reports by multiple regulators should eventually reduce the number of audits for manufacturers. Study Group 2 was initially tasked with the responsibility of developing guidance documents that will be used for the exchange of adverse event reports. As a result of its efforts, this group developed SG2N54R8:2006. SG2N54R8:2006 (final document), entitled ‘‘Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices,’’ provides guidance on the type of adverse events associated with medical devices that should be reported by manufacturers to a National Competent Authority. It elaborates on the regulatory requirements existing in the participating member countries. sroberts on PROD1PC70 with NOTICES II. Significance of Guidance These documents represent recommendations from the GHTF study groups and do not describe regulatory requirements. FDA is making these documents available so that industry and other members of the public may express their views and opinions. III. Electronic Access Persons interested in obtaining a copy of the documents may also do so by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic VerDate Aug<31>2005 16:03 Feb 05, 2007 Jkt 211001 submissions, Mammography Matters, and other device-oriented information. Information on the GHTF may be accessed at http://www.ghtf.org. The CDRH web site may be accessed at http://www.fda.gov/cdrh. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding these documents. 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. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 30, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–1864 Filed 2–5–07; 8:45 am] 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) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104–13), the Health Resources and Services Administration (HRSA) will publish 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, 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 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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: Reporting Form for the MCHB National Hemophilia Program Grantees and Hemophilia Treatment Center (HTC) Affiliates Having Factor Replacement Product (FRP) Programs—NEW The Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA) is planning to implement an annual reporting form required of grantees of the MCHB National Hemophilia Program and their HTC affiliates having a factor replacement product (FRP) program. The purpose of the form is to provide systematic information and data comprising a financial overview of the FRP programs of the HTCs receiving funding through grantees of the MCHB National Hemophilia Program. The proposed form will constitute a reporting requirement for the MCHB National Hemophilia Program grantees and their affiliate HTCs having FRP programs. Data from the form will provide quantitative information on the financial and services provision aspects of each of the HTC FRP programs under each of the MCHB National Hemophilia Program grantees, specifically: (a) Patient FRP program participation, (b) FRP program revenue, (c) FRP program costs, (d) FRP program net income, and (e) use of FRP program net income. This form will provide data useful to grantees and their affiliate HTCs having FRP programs. Useful data will also be provided to the MCHB National Hemophilia Program in order to assess FRP program performance including FRP program operational costs appropriateness, FRP program cost efficiency, and FRP program services benefits-information that is essential to evaluating HTCs having FRP programs, grantees, and the MCHB National Hemophilia Program. Each HTC having an FRP program is to submit its report to the grantee and each grantee is to submit the individual reports of each of their affiliate HTCs having an FRP program to the MCHB National Hemophilia Program as a part of their annual grant application. The burden estimate for this project is as follows: E:\FR\FM\06FEN1.SGM 06FEN1 5445 Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices Form Number of respondents Average number of responses per respondent Total responses Hours per response Total burden hours Factor Replacement Product (FRP) Data Sheet ................. 68 1 68 30 2040 Agency Information Collection Activities: Proposed Collection: Comment Request 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. 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, Public Law 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Proposed Project: ‘‘Health Care and Other Facilities’’ Construction Program: Web-Based Status Reporting Form: NEW The Health Resources and Services Administration’s Health Care and Other Facilities (HCOF) construction program provides earmarked funds to healthrelated facilities for construction-related activities and/or capital equipment purchases. Awarded facilities are Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10–33 Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received within 60 days of this notice. Dated: January 29, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7–1824 Filed 2–5–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Project type (current) Responses per respondent Number of respondents required to provide a periodic (quarterly for construction-related projects, annually for equipment only projects) update of the status of the funded project until it is completed. The monitoring period averages about 3 years, although some projects take up to 5 years to complete. The information collected from these updates is vital to program management staff to determine whether projects are progressing according to the established timeframes, meeting deadlines established in the Notice of Grant Award (NGA), and funds are drawn down appropriately. The data collected from the updates is also shared with both the Division of Grants Management Operations (DGMO) and the Division of Engineering Services (DES), so that they can assist in the overall evaluation of each project’s progress. A Web-based form has been developed for progress reporting for the HCOF program. This form will provide awardees access to directly input the required status update information in a timely, consistent, and uniform manner. The Web-based form will minimize burden to respondents and will inform respondents when there are missing data elements prior to submission. The estimate of burden for the forms is as follows: Total responses Hours per response Total burden hours Construction-Related ......................................................... Equipment Only ................................................................. 325 357 4 1 1,300 357 .5 .5 650 178.5 Total ............................................................................ 682 ........................ 1,657 ........................ 828.5 Project type (FY 07–09 projection) Responses per espondent Number of respondents Total responses Hours per response 498 925 4 1 1,992 925 .5 .5 Total ............................................................................ sroberts on PROD1PC70 with NOTICES Construction-Related* ........................................................ Equipment Only** ............................................................... 1,423 ........................ 2,917 ........................ VerDate Aug<31>2005 16:03 Feb 05, 2007 Jkt 211001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\06FEN1.SGM 06FEN1 Total burden hours 996 462.5 1,458

Agencies

[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Notices]
[Pages 5444-5445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1824]


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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) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Public Law 104-13), the Health Resources and Services 
Administration (HRSA) will publish 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, 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: Reporting Form for the MCHB National Hemophilia 
Program Grantees and Hemophilia Treatment Center (HTC) Affiliates 
Having Factor Replacement Product (FRP) Programs--NEW

    The Maternal and Child Health Bureau (MCHB) of the Health Resources 
and Services Administration (HRSA) is planning to implement an annual 
reporting form required of grantees of the MCHB National Hemophilia 
Program and their HTC affiliates having a factor replacement product 
(FRP) program. The purpose of the form is to provide systematic 
information and data comprising a financial overview of the FRP 
programs of the HTCs receiving funding through grantees of the MCHB 
National Hemophilia Program. The proposed form will constitute a 
reporting requirement for the MCHB National Hemophilia Program grantees 
and their affiliate HTCs having FRP programs.
    Data from the form will provide quantitative information on the 
financial and services provision aspects of each of the HTC FRP 
programs under each of the MCHB National Hemophilia Program grantees, 
specifically: (a) Patient FRP program participation, (b) FRP program 
revenue, (c) FRP program costs, (d) FRP program net income, and (e) use 
of FRP program net income. This form will provide data useful to 
grantees and their affiliate HTCs having FRP programs. Useful data will 
also be provided to the MCHB National Hemophilia Program in order to 
assess FRP program performance including FRP program operational costs 
appropriateness, FRP program cost efficiency, and FRP program services 
benefits-information that is essential to evaluating HTCs having FRP 
programs, grantees, and the MCHB National Hemophilia Program.
    Each HTC having an FRP program is to submit its report to the 
grantee and each grantee is to submit the individual reports of each of 
their affiliate HTCs having an FRP program to the MCHB National 
Hemophilia Program as a part of their annual grant application.
    The burden estimate for this project is as follows:

[[Page 5445]]



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                                                                                       Average number
                                Form                                    Number of       of responses        Total          Hours per       Total burden
                                                                       respondents     per respondent     responses         response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Factor Replacement Product (FRP) Data Sheet........................              68                1               68               30             2040
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville, 
Maryland 20857. Written comments should be received within 60 days of 
this notice.

    Dated: January 29, 2007.
Caroline Lewis,
Acting Associate Administrator for Administration and Financial 
Management.
 [FR Doc. E7-1824 Filed 2-5-07; 8:45 am]
BILLING CODE 4165-15-P