Agency Information Collection Activities; Proposed Collection; Comment Request, 17416-17417 [2013-06528]

Download as PDF 17416 Federal Register / Vol. 78, No. 55 / Thursday, March 21, 2013 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 2012, THROUGH DECEMBER 31, 2012 PMA No., Docket No. Applicant Trade name P110038, FDA–2012–M–1012 .............. Bolton Medical Inc ................................ P110042, FDA–2012–M–1048 .............. Cameron Health, Inc ............................ P100003, FDA–2012–M–1039 .............. Globus Medical, Inc ............................. Relay® Thoracic Stent-Graft with Plus Delivery System. Subcutaneous Implantable Defibrillator (S–ICD®) System. Secure-C Artificial Cervical Disc .......... P120005, FDA–2012–M–1049 .............. Dexcom, Inc ......................................... P120006, FDA–2012–M–1110 .............. P120007, FDA–2012–M–1066 .............. TriVascular, Inc .................................... Gen-Probe, Inc ..................................... P110008, FDA–2012–M–1085 .............. P110039, FDA–2012–M–1084 .............. P110021, FDA–2012–M–1088 .............. Paradigm Spine, LLC ........................... InSightec, Inc ....................................... Edwards Lifesciences, LLC .................. P100040/S008, FDA–2012–M–1109 ..... Medtronic Vascular .............................. P100012, FDA–2012–M–1111 .............. P120002, FDA–2012–M–1183 .............. NuVasive, Inc ....................................... Cordis Corporation ............................... P100022, FDA–2012–M–1146 .............. Cook, Inc .............................................. P100047, FDA–2012–M–1184 .............. HeartWare, Inc ..................................... P120008, FDA–2012–M–1176 .............. Abbott Laboratories .............................. II. Electronic Access Persons with access to the Internet may obtain the documents at http:// www.fda.gov/MedicalDevices/Products andMedicalProcedures/Device ApprovalsandClearances/PMA Approvals/default.htm. Dated: March 15, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06429 Filed 3–20–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Comment Request emcdonald on DSK67QTVN1PROD with NOTICES ACTION: Notice. SUMMARY: 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 VerDate Mar<14>2013 15:09 Mar 20, 2013 Jkt 229001 Dexcom G4 PLATINUM Continuous Glucose Monitoring System. Ovation Abdominal Stent Graft System APTIMA® HPV 16 18/45 Genotype Assay. coflex® Interlaminar Technology .......... InSightec ExAblate® System ............... Edwards SAPIENTM Transcatheter Heart Valve. Valiant® Thoracic Stent Graft with the Captivia Delivery System. PCM® Cervical Disc System ................ S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems.. Zilver PTX Drug-Eluting Peripheral Stent. HeartWare® Ventricular Assist System ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls. 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, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: Ryan White HIV/AIDS Treatment Extension Act of 2009, Part A Minority AIDS Initiative Report (the Part A MAI Report): (OMB No. 0915–0304)— EXTENSION Abstract: HRSA’s HIV/AIDS Bureau (HAB) administers the Ryan White HIV/ AIDS Part A Program authorized under Title XXVI of the Public Health Service Act (Ryan White HIV/AIDS Treatment Extension Act of 2009). Part A provides emergency relief for areas with substantial need for HIV/AIDS care and PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Approval date September 21, 2012. September 28, 2012. September 28, 2012. October 5, 2012. October 5, 2012. October 12, 2012. October 17, 2012. October 18, 2012. October 19, 2012. October 26, 2012. October 26, 2012. November 7, 2012 November 14, 2012. November 20, 2012. November 28, 2012. support services that are most severely affected by the HIV/AIDS epidemic, including eligible metropolitan areas (EMAs) and Transitional Grant Areas (TGAs). As a component of Part A, the purpose of the Minority AIDS Initiative (MAI) Supplement is to improve access to high quality HIV care, services, and outcomes for individuals in disproportionately impacted communities of color who are living with HIV disease, including African Americans, Latinos, Native Americans, Asian Americans, Native Hawaiians, and Pacific Islanders (Section 2693(b)(2)(A) of the Public Health Service (PHS) Act). Since the purpose of the Part A MAI is to expand access to medical, health, and social support services for disproportionately impacted racial/ethnic minority populations living with HIV/AIDS, it is important that HRSA is able to report on minorities served by the Part A MAI. The Part A MAI Report is a data collection instrument in which grantees report on the number and characteristics of clients served and services provided. The Part A MAI Report, first approved for use in March 2006, is designed to collect performance data from Part A grantees. The report has two parts: (1) A web-based data entry application that collects standardized quantitative and qualitative information and (2) an accompanying narrative report. Grantees E:\FR\FM\21MRN1.SGM 21MRN1 Federal Register / Vol. 78, No. 55 / Thursday, March 21, 2013 / Notices submit two Part A MAI Reports annually: The Part A MAI Plan (Plan) and the Part A MAI Year-End Annual Report (Annual Report). The Plan and Annual Report components of the report are linked to minimize the reporting burden and include drop-down menu responses; fields for reporting budget, expenditure, and aggregated client level data; and open-ended responses for describing client or service-level outcomes. Together, the Plan and Annual Report components collect information from grantees on MAIfunded services, expenditure patterns, the number and demographics of clients served, and client-level outcomes. The MAI Plan Narrative that accompanies the Plan web forms provides: (1) An explanation of the data submitted in the Plan web forms; (2) a summary of the Plan, including the plan and timeline for disbursing funds, monitoring service delivery, and implementing any service-related capacity development or technical assistance activities; and (3) the plan and timeline for documenting clientlevel outcome measures. In addition, if the EMA/TGA revised any planned services, allocation amounts, or target communities after their grant application was submitted, the changes must be highlighted and explained. The accompanying MAI Annual Report Narrative describes: (1) Progress towards achieving specific goals and objectives identified in the grantee’s approved MAI Plan for that fiscal year and in linking MAI services/activities to Part A and other Ryan White Program services; (2) achievements in relation to clientlevel health outcomes; (3) summary of challenges or barriers at the provider or grantee levels, the strategies and/or action steps implemented to address them, and lessons learned; and (4) discussion of MAI technical assistance needs identified by the EMA/TGA. This information is needed to monitor and assess: (1) Changes in the type and amount of HIV/AIDS health care and related services being provided to each disproportionately impacted community of color; (2) the aggregate number of persons receiving HIV/AIDS services within each racial and ethnic community; and (3) the impact of Part A MAI-funded services in terms of client-level and service-level health outcomes. This information also is used to plan new technical assistance and 17417 capacity development activities, and influence the HRSA policy and program management functions. The data provided to HRSA does not contain individual or personally identifiable information. No changes have been made to the Part A MAI Report. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: Form name Number of respondents Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Part A MAI Report ........................................... 53 2 106 5 530 Note: Data collection system enhancements have resulted in a shortened response burden (from 6 to 5 total hours per response) for respondents since the previous OMB approval request. Submit your comments to paperwork@hrsa.gov or mail the HRSA Reports Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Deadline: Comments on this Information Collection Request must be received within 60 days of this notice. ADDRESSES: Dated: March 14, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. emcdonald on DSK67QTVN1PROD with NOTICES [FR Doc. 2013–06528 Filed 3–20–13; 8:45 am] BILLING CODE 4165–15–P VerDate Mar<14>2013 15:09 Mar 20, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request ACTION: Notice. SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443–1984. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Information Collection Request Title: Organ and Tissue Donor and Recipient Life Stories Form (OMB No. 0915– xxxx)—NEW Abstract: HRSA’s Division of Transplantation (DoT) is the primary entity in the Department of Health and Human Services (HHS) responsible for the Organ Transplant Program established under the National Organ Transplant Act (Pub. L. 98–507, codified at sections 371–377D of the Public Health Service (PHS) Act). Section 377A of the PHS Act authorizes the Secretary of HHS to establish a public education program to increase awareness about organ donation and the need to provide for an adequate rate of such donations. In brief, DoT’s responsibilities are twofold: (1) To provide oversight and guidance to the national organ transplant system in the U.S. including monitoring the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients, and (2) to implement a program of public and professional education and outreach aimed at increasing the number of organ donors E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Pages 17416-17417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities; Proposed Collection; 
Comment Request

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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, email paperwork@hrsa.gov or 
call the HRSA Reports Clearance Officer at (301) 443-1984.
    HRSA especially requests comments on: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions, (2) the accuracy of the estimated burden, (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected, and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.

Information Collection Request Title: Ryan White HIV/AIDS Treatment 
Extension Act of 2009, Part A Minority AIDS Initiative Report (the Part 
A MAI Report): (OMB No. 0915-0304)--EXTENSION

    Abstract: HRSA's HIV/AIDS Bureau (HAB) administers the Ryan White 
HIV/AIDS Part A Program authorized under Title XXVI of the Public 
Health Service Act (Ryan White HIV/AIDS Treatment Extension Act of 
2009). Part A provides emergency relief for areas with substantial need 
for HIV/AIDS care and support services that are most severely affected 
by the HIV/AIDS epidemic, including eligible metropolitan areas (EMAs) 
and Transitional Grant Areas (TGAs). As a component of Part A, the 
purpose of the Minority AIDS Initiative (MAI) Supplement is to improve 
access to high quality HIV care, services, and outcomes for individuals 
in disproportionately impacted communities of color who are living with 
HIV disease, including African Americans, Latinos, Native Americans, 
Asian Americans, Native Hawaiians, and Pacific Islanders (Section 
2693(b)(2)(A) of the Public Health Service (PHS) Act). Since the 
purpose of the Part A MAI is to expand access to medical, health, and 
social support services for disproportionately impacted racial/ethnic 
minority populations living with HIV/AIDS, it is important that HRSA is 
able to report on minorities served by the Part A MAI.
    The Part A MAI Report is a data collection instrument in which 
grantees report on the number and characteristics of clients served and 
services provided. The Part A MAI Report, first approved for use in 
March 2006, is designed to collect performance data from Part A 
grantees. The report has two parts: (1) A web-based data entry 
application that collects standardized quantitative and qualitative 
information and (2) an accompanying narrative report. Grantees

[[Page 17417]]

submit two Part A MAI Reports annually: The Part A MAI Plan (Plan) and 
the Part A MAI Year-End Annual Report (Annual Report). The Plan and 
Annual Report components of the report are linked to minimize the 
reporting burden and include drop-down menu responses; fields for 
reporting budget, expenditure, and aggregated client level data; and 
open-ended responses for describing client or service-level outcomes. 
Together, the Plan and Annual Report components collect information 
from grantees on MAI-funded services, expenditure patterns, the number 
and demographics of clients served, and client-level outcomes.
    The MAI Plan Narrative that accompanies the Plan web forms 
provides: (1) An explanation of the data submitted in the Plan web 
forms; (2) a summary of the Plan, including the plan and timeline for 
disbursing funds, monitoring service delivery, and implementing any 
service-related capacity development or technical assistance 
activities; and (3) the plan and timeline for documenting client-level 
outcome measures. In addition, if the EMA/TGA revised any planned 
services, allocation amounts, or target communities after their grant 
application was submitted, the changes must be highlighted and 
explained. The accompanying MAI Annual Report Narrative describes: (1) 
Progress towards achieving specific goals and objectives identified in 
the grantee's approved MAI Plan for that fiscal year and in linking MAI 
services/activities to Part A and other Ryan White Program services; 
(2) achievements in relation to client-level health outcomes; (3) 
summary of challenges or barriers at the provider or grantee levels, 
the strategies and/or action steps implemented to address them, and 
lessons learned; and (4) discussion of MAI technical assistance needs 
identified by the EMA/TGA.
    This information is needed to monitor and assess: (1) Changes in 
the type and amount of HIV/AIDS health care and related services being 
provided to each disproportionately impacted community of color; (2) 
the aggregate number of persons receiving HIV/AIDS services within each 
racial and ethnic community; and (3) the impact of Part A MAI-funded 
services in terms of client-level and service-level health outcomes. 
This information also is used to plan new technical assistance and 
capacity development activities, and influence the HRSA policy and 
program management functions. The data provided to HRSA does not 
contain individual or personally identifiable information. No changes 
have been made to the Part A MAI Report.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions, to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information, to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information, and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                           Average burden    Total
          Form name               Number of        responses per     Total  responses  per response  (in  burden
                                 respondents         respondent                              hours)        hours
----------------------------------------------------------------------------------------------------------------
Part A MAI Report...........                53                  2                106                  5   530
----------------------------------------------------------------------------------------------------------------

    Note: Data collection system enhancements have resulted in a 
shortened response burden (from 6 to 5 total hours per response) for 
respondents since the previous OMB approval request.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers 
Lane, Rockville, MD 20857.
    Deadline: Comments on this Information Collection Request must be 
received within 60 days of this notice.

    Dated: March 14, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-06528 Filed 3-20-13; 8:45 am]
BILLING CODE 4165-15-P