Proposed Information Collection Activity; Comment Request, 12328-12329 [2013-03787]

Download as PDF 12328 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices Barbara Ferrer, Executive Director, Boston Public Health Commission; Shelby Gonzales, Senior Health Outreach Associate, Center on Budget & Policy Priorities; Jan Henning, Benefits Counseling & Special Projects Coordinator, North Central Texas Council of Governments’ Area Agency on Aging; Warren Jones, Executive Director, Mississippi Institute for Improvement of Geographic Minority Health; Cathy Kaufmann, Administrator, Oregon Health Authority; Sandy Markwood, Chief Executive Officer, National Association of Area Agencies on Aging; Miriam Mobley-Smith, Dean, Chicago State University, College of Pharmacy; Ana Natale-Pereira, Associate Professor of Medicine, University of Medicine & Dentistry of New Jersey; Megan Padden, Vice President, Sentara Health Plans; David W. Roberts, Vice-President, Healthcare Information and Management System ¨ Society; Julie Boden Schmidt, Associate Vice President, National Association of Community Health Centers; Alan Spielman, President & Chief Executive Officer, URAC; Winston Wong, Medical Director, Community Benefit Director, Kaiser Permanente and Darlene YeeMelichar, Professor & Coordinator, San Francisco State University. The agenda for the March 27, 2013 meeting will include the following: • Welcome and Listening Session with CMS Leadership • Recap of the Previous (December 18, 2012) Meeting • Affordable Care Act Initiatives • An Opportunity for Public Comment • Meeting Summary, Review of Recommendations, and Next Steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make a presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102–3). (Catalog of Federal Domestic Assistance Program No. 93.733, Medicare—Hospital Insurance Program; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: February 13, 2013. Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2013–03928 Filed 2–21–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Project LAUNCH Cross-Site Evaluation. OMB No.: 0970–0373. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is collecting data as part of a cross-site evaluation of a Substance Abuse and Mental Health Services Administration(SAMHSA) initiative called Project LAUNCH (Linking Actions for Unmet Needs in Children’s Health). Project LAUNCH promotes the healthy development and wellness of children ages birth to eight years. A total of 35 Project LAUNCH grantees are funded to improve coordination among child-serving systems, build infrastructure, and improve methods for providing services. Grantees implement a range of public health strategies to support young child wellness in a designated locality. Grants were awarded in four cohorts. Three of these cohorts will end on a rolling basis over the next three years and one cohort of grantees was recently awarded and will end in five years. Annual estimates of burden take into account rolling graduation of cohorts and represent an average of burden over three years. Data for the cross-site evaluation of Project LAUNCH will be collected through: (1) Interviews conducted either via telephone or during site-visits to Project LAUNCH grantees, (2) semiannual reports that will be submitted electronically on a web-based data reporting system, and (3) outcome data tables included in grantee specific endof-year evaluation reports. During either telephone interviews or the site visits, researchers will conduct interviews with Project LAUNCH service providers and collaborators in states/tribes and local communities of focus. Interviewers will ask program administrators questions about all Project LAUNCH activities, including: Infrastructure development; collaboration and coordination among partner agencies, organizations, and service providers; and development, implementation, and refinement of service strategies. As part of the proposed data collection, Project LAUNCH staff will be asked to submit semi-annual electronic reports on state/tribal and local systems development and on services that children and families receive. The electronic data reports also will collect data about other Project LAUNCHfunded service enhancements, such as trainings, Project LAUNCH systems change activities, and changes in provider settings and practice. Information provided in these reports will be aggregated on a quarterly basis, and reported semi-annually. As a final part of the proposed data collection, the cross-site evaluation will utilize outcome data provided by grantee evaluators as part of their endof-year evaluation reports to the SAMHSA. Information provided in these reports is aggregated. Respondents: State/Tribal Child Wellness Coordinator, Local Child Wellness Coordinator, Chair of the State/Tribal Child Wellness Council (during site visit only), Chair of the Community Child Wellness Council, and Local Service Providers/ Stakeholders. sroberts on DSK5SPTVN1PROD with NOTICES ANNUAL BURDEN ESTIMATES Total number of respondents Instrument Number of responses per respondent Average burden hours per response 19 19 114 19 11 19 1 1 1 1 1 2 1.5 1 .75 1.25 1.25 4 Child Wellness Coordinator Interview Guide ....................... Chair of Local Child Wellness Council Interview Guide ...... Local Stakeholder Interview Guide ...................................... State Child Wellness Coordinator Interview Guide ............. Chair of State Child Wellness Council Interview Guide ...... Electronic Data Reporting: Systems Measures ................... VerDate Mar<15>2010 16:18 Feb 21, 2013 Jkt 229001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1 Total burden hours 87 57 258 72 14 456 Annual burden hours 29 19 86 24 14 152 12329 Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices ANNUAL BURDEN ESTIMATES—Continued Total number of respondents Number of responses per respondent Average burden hours per response 19 27 Instrument 2 1 8 8 Electronic Data Reporting: Services Measures ................... Outcomes Data Tables in End of Year Reports .................. Estimated Total Annual Burden Hours: 844. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments 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) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2013–03787 Filed 2–21–13; 8:45 am] sroberts on DSK5SPTVN1PROD with NOTICES BILLING CODE 4184–22–M VerDate Mar<15>2010 16:18 Feb 21, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0114] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.’’ This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 23, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to http:// SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Total burden hours 912 648 Annual burden hours 304 216 www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ron Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2654, Silver Spring, MD 20993–0002, 301–796–6163. I. Background Defects or performance failures of marketed medical devices can pose serious risks to public health. Recalls serve both to correct the defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device failure or function. The recall process establishes a mechanism for firms that produce and market medical devices to take timely action to correct violative devices or remove them from the marketplace when correction or removal is necessary to protect the public health. When a firm’s recall process is operating effectively, the firm identifies a device defect or failure, determines a recall is appropriate, and triggers the initiation of the recall process. However, firms may have trouble identifying whether a change to a device meets the definition of a recall, the appropriate scope of a recall, and when FDA should be notified of a recall. These issues can result in delays in notifying the public about unsafe medical devices. FDA also recognizes that continuous improvement activities, as part of an effective quality system, often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient. When new iterations of a device involve improvements to device design, it does not necessarily mean that the existing device needs to be recalled. Such changes may be appropriately characterized instead as product enhancements. In addition to determining whether a proposed change to a marketed device meets the definition of a device recall or E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12328-12329]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Title: Project LAUNCH Cross-Site Evaluation.
    OMB No.: 0970-0373.
    Description: The Administration for Children and Families (ACF), 
U.S. Department of Health and Human Services, is collecting data as 
part of a cross-site evaluation of a Substance Abuse and Mental Health 
Services Administration(SAMHSA) initiative called Project LAUNCH 
(Linking Actions for Unmet Needs in Children's Health). Project LAUNCH 
promotes the healthy development and wellness of children ages birth to 
eight years. A total of 35 Project LAUNCH grantees are funded to 
improve coordination among child-serving systems, build infrastructure, 
and improve methods for providing services. Grantees implement a range 
of public health strategies to support young child wellness in a 
designated locality.
    Grants were awarded in four cohorts. Three of these cohorts will 
end on a rolling basis over the next three years and one cohort of 
grantees was recently awarded and will end in five years. Annual 
estimates of burden take into account rolling graduation of cohorts and 
represent an average of burden over three years.
    Data for the cross-site evaluation of Project LAUNCH will be 
collected through: (1) Interviews conducted either via telephone or 
during site-visits to Project LAUNCH grantees, (2) semi-annual reports 
that will be submitted electronically on a web-based data reporting 
system, and (3) outcome data tables included in grantee specific end-
of-year evaluation reports.
    During either telephone interviews or the site visits, researchers 
will conduct interviews with Project LAUNCH service providers and 
collaborators in states/tribes and local communities of focus. 
Interviewers will ask program administrators questions about all 
Project LAUNCH activities, including: Infrastructure development; 
collaboration and coordination among partner agencies, organizations, 
and service providers; and development, implementation, and refinement 
of service strategies.
    As part of the proposed data collection, Project LAUNCH staff will 
be asked to submit semi-annual electronic reports on state/tribal and 
local systems development and on services that children and families 
receive. The electronic data reports also will collect data about other 
Project LAUNCH-funded service enhancements, such as trainings, Project 
LAUNCH systems change activities, and changes in provider settings and 
practice. Information provided in these reports will be aggregated on a 
quarterly basis, and reported semi-annually.
    As a final part of the proposed data collection, the cross-site 
evaluation will utilize outcome data provided by grantee evaluators as 
part of their end-of-year evaluation reports to the SAMHSA. Information 
provided in these reports is aggregated.
    Respondents: State/Tribal Child Wellness Coordinator, Local Child 
Wellness Coordinator, Chair of the State/Tribal Child Wellness Council 
(during site visit only), Chair of the Community Child Wellness 
Council, and Local Service Providers/Stakeholders.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                     Number of    Average burden
           Instrument              Total number    responses per     hours per     Total burden    Annual burden
                                  of respondents    respondent       response          hours           hours
----------------------------------------------------------------------------------------------------------------
Child Wellness Coordinator                    19               1             1.5              87              29
 Interview Guide................
Chair of Local Child Wellness                 19               1               1              57              19
 Council Interview Guide........
Local Stakeholder Interview                  114               1             .75             258              86
 Guide..........................
State Child Wellness Coordinator              19               1            1.25              72              24
 Interview Guide................
Chair of State Child Wellness                 11               1            1.25              14              14
 Council Interview Guide........
Electronic Data Reporting:                    19               2               4             456             152
 Systems Measures...............

[[Page 12329]]

 
Electronic Data Reporting:                    19               2               8             912             304
 Services Measures..............
Outcomes Data Tables in End of                27               1               8             648             216
 Year Reports...................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 844.
    In compliance with the requirements of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 370 L'Enfant Promenade, SW., 
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email 
address: OPREinfocollection@acf.hhs.gov. All requests should be 
identified by the title of the information collection.
    The Department specifically requests comments 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) 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. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2013-03787 Filed 2-21-13; 8:45 am]
BILLING CODE 4184-22-M