Agency Information Collection Activities: Submission for OMB Review: Comment Request, 61105-61106 [2011-25339]

Download as PDF 61105 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Submission of information for de novo petition program Number of respondents Number of responses per respondent per year Average burden per respondent (in hours) Total annual responses Total hours CDRH ................................................................................... CBER ................................................................................... 25 1 1 1 25 1 100 100 2,500 100 Total .............................................................................. ........................ ........................ ........................ ........................ 2,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are medical device manufacturers seeking to market medical device products that have been classified into class III under section 513(f)(2) of the FD&C Act. Based on FDA’s experience with the de novo petition program, FDA expects the program to continue to be utilized as a viable program in the future. It is expected that the number of petitions will increase over its current rate and reach a steady rate of approximately 26 submissions per year FDA estimates from past experience with the de novo petition program that the complete process involved with the program takes approximately 100 hours. This average is based upon estimates by FDA administrative and technical staff who are familiar with the requirements for submission of a de novo petition (and related materials), have consulted and advised manufacturers on these requirements, and have reviewed the documentation submitted. Therefore, the total reporting burden hours is estimated to be 2,600 hours. TABLE 2 Number of respondents Total burden hours annualized Hourly wage rate Total cost annualized 26 ................................................................................................................................................. 100 $150 $390,000 The average to industry per hour for this type of work is $150, resulting in a cost of $15,000 per respondent. The estimated submission cost of $15,000 multiplied by 26 submissions per year equals $390,000, which is the aggregated industry reporting cost annualized. This draft guidance also refers to currently approved information collections found in FDA regulations. The collections of information in 21 CFR part 807, subpart E, are approved under OMB control number 0910–0120. srobinson on DSK4SPTVN1PROD with NOTICES V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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. VerDate Mar<15>2010 16:42 Sep 30, 2011 Jkt 223001 Dated: September 27, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–25367 Filed 9–30–11; 8:45 am] BILLING CODE 4160–01–P 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, 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, call the HRSA Reports Clearance Office at (301) 443–1129. The following request has been submitted to OMB for review under the Paperwork Reduction Act of 1995: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Proposed Project: ADAP Data Report— [New] HRSA’s AIDS Drug Assistance Program (ADAP) is funded through the Ryan White HIV/AIDS Program, Part B, of Title XXVI of the Public Health Service Act, which provides grants to states and territories. Each of the 50 states, the District of Columbia, Puerto Rico, and several territories receive ADAP grants. The ADAP provides medications for the treatment of HIV/ AIDS. Program funds may also be used to purchase health insurance for eligible clients or for services that enhance access, adherence, and monitoring of drug treatments. The Ryan White HIV/AIDS Program specifies HRSA’s responsibilities in the administration of grant funds, the allocation of funds, the evaluation of programs for the population served, and the improvement of quality of care. Accurate records of the grantees receiving Ryan White HIV/AIDS Program funding, the services provided, and the clients served, continue to be critical issues for the implementation of the legislation and are necessary for HRSA to fulfill its responsibilities. The ADAP Data Report (ADR) provides data on the characteristics of ADAP grantees and the clients being served with program funds. The ADR is E:\FR\FM\03OCN1.SGM 03OCN1 61106 Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices intended to support clinical quality management, performance measurement, service delivery, and client monitoring at the system and client levels. The reporting system consists of an online data form—the Grantee Report—and a data file containing the client-level data elements. Data will be submitted every six months. The Grantee Report includes information about program administration, funding, and expenditures, in addition to the medication formulary. The client-level data include demographic, clinical, enrollment, and service data for each patient who is determined eligible and enrolled in the ADAP. The legislation specifies grantee accountability and links budget to performance. The ADR will be used to ensure compliance with the requirements of the legislation, to evaluate the progress of programs, to monitor grantee performance, to measure the Government Performance and Results Act (GPRA) and the Performance Assessment Rating Tool (PART) goals, and to meet reporting responsibilities to the Department, Congress, and OMB. In addition to meeting the goal of accountability to Congress, clients, advocacy groups, and the general public, information collected through the ADR is critical to HRSA and grantees for assessing the status of existing HIV-related service delivery systems, investigating trends in service utilization, and identifying the areas of greatest need. Discussions were held with nine volunteer grantee agencies representing a variety of ADAP models, as a basis for the burden estimates for the ADR that follows. These burden estimates are presented in two tables. The first table represents the estimated burden for the Number of respondents Instrument Responses per respondent first year, including the estimated time to adjust existing or develop new data collection systems to collect the elements that HRSA is requesting. This is a one-time burden for grantees and will not be a factor after the first year. The second table represents the estimated burden for subsequent years. The Grantee Report burden remains unchanged across the three years of the information collection, as the submission is consistent with current reporting requirements. The Client Report burden is expected to decrease slightly in subsequent years as grantees become more proficient with reporting client-level data, based on feedback and technical assistance resources that HRSA will provide. The annual estimate of burden for the first year of the information collection is as follows: Total responses Hours per response Total burden hours Grantee Report .................................................................... Client Report ........................................................................ Data Collection System ....................................................... 57 57 57 2 2 1 114 114 57 12.50 34.19 826.00 1,425.00 3,897.66 47,082.00 Total: ............................................................................. ........................ ........................ ........................ ........................ 52,404.66 Number of respondents Responses per respondent Total responses Hours per response The annual estimate of burden for subsequent years is as follows: Instrument Total burden hours Grantee Report .................................................................... Client Report ........................................................................ 57 57 2 2 114 114 12.50 24.00 1,425.00 2,736.00 Total: ............................................................................. ........................ ........................ ........................ ........................ 4,161.00 srobinson on DSK4SPTVN1PROD with NOTICES 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 email 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: September 26, 2011. Wendy Ponton, Director, Office of Management. [FR Doc. 2011–25339 Filed 9–30–11; 8:45 am] BILLING CODE 4165–15–P VerDate Mar<15>2010 16:42 Sep 30, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Intent To Prepare an Environmental Impact Statement Summary: In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (HHS), is issuing this notice to advise the public that an environmental impact statement will be prepared for the NIH Animal Center at Poolesville Master Plan, Poolesville, Montgomery County, Maryland. For Further Information Contact: Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301–496– 7775; fax 301–480–8056; or e-mail nihnepa@mail.nih.gov. Supplementary Information: The NIH Animal Center is located on 513 acres 4 miles southwest of the City of Poolesville, a small agricultural community located in western Maryland. The campus is a component of the National Institutes of Health (NIH), one of the world’s largest biomedical research facilities and the Federal government’s focal point for medical and behavioral research. The NIH Animal Center at Poolesville is a major extension of animal holding and production facilities at Bethesda and consists of a number of buildings used to house, quarantine, and study the E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Pages 61105-61106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25339]


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

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, 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, call the 
HRSA Reports Clearance Office at (301) 443-1129. The following request 
has been submitted to OMB for review under the Paperwork Reduction Act 
of 1995:

Proposed Project: ADAP Data Report--[New]

    HRSA's AIDS Drug Assistance Program (ADAP) is funded through the 
Ryan White HIV/AIDS Program, Part B, of Title XXVI of the Public Health 
Service Act, which provides grants to states and territories. Each of 
the 50 states, the District of Columbia, Puerto Rico, and several 
territories receive ADAP grants. The ADAP provides medications for the 
treatment of HIV/AIDS. Program funds may also be used to purchase 
health insurance for eligible clients or for services that enhance 
access, adherence, and monitoring of drug treatments.
    The Ryan White HIV/AIDS Program specifies HRSA's responsibilities 
in the administration of grant funds, the allocation of funds, the 
evaluation of programs for the population served, and the improvement 
of quality of care. Accurate records of the grantees receiving Ryan 
White HIV/AIDS Program funding, the services provided, and the clients 
served, continue to be critical issues for the implementation of the 
legislation and are necessary for HRSA to fulfill its responsibilities.
    The ADAP Data Report (ADR) provides data on the characteristics of 
ADAP grantees and the clients being served with program funds. The ADR 
is

[[Page 61106]]

intended to support clinical quality management, performance 
measurement, service delivery, and client monitoring at the system and 
client levels. The reporting system consists of an online data form--
the Grantee Report--and a data file containing the client-level data 
elements. Data will be submitted every six months. The Grantee Report 
includes information about program administration, funding, and 
expenditures, in addition to the medication formulary. The client-level 
data include demographic, clinical, enrollment, and service data for 
each patient who is determined eligible and enrolled in the ADAP.
    The legislation specifies grantee accountability and links budget 
to performance. The ADR will be used to ensure compliance with the 
requirements of the legislation, to evaluate the progress of programs, 
to monitor grantee performance, to measure the Government Performance 
and Results Act (GPRA) and the Performance Assessment Rating Tool 
(PART) goals, and to meet reporting responsibilities to the Department, 
Congress, and OMB.
    In addition to meeting the goal of accountability to Congress, 
clients, advocacy groups, and the general public, information collected 
through the ADR is critical to HRSA and grantees for assessing the 
status of existing HIV-related service delivery systems, investigating 
trends in service utilization, and identifying the areas of greatest 
need.
    Discussions were held with nine volunteer grantee agencies 
representing a variety of ADAP models, as a basis for the burden 
estimates for the ADR that follows. These burden estimates are 
presented in two tables. The first table represents the estimated 
burden for the first year, including the estimated time to adjust 
existing or develop new data collection systems to collect the elements 
that HRSA is requesting. This is a one-time burden for grantees and 
will not be a factor after the first year. The second table represents 
the estimated burden for subsequent years. The Grantee Report burden 
remains unchanged across the three years of the information collection, 
as the submission is consistent with current reporting requirements. 
The Client Report burden is expected to decrease slightly in subsequent 
years as grantees become more proficient with reporting client-level 
data, based on feedback and technical assistance resources that HRSA 
will provide.
    The annual estimate of burden for the first year of the information 
collection is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
           Instrument               respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Grantee Report..................              57               2             114           12.50        1,425.00
Client Report...................              57               2             114           34.19        3,897.66
Data Collection System..........              57               1              57          826.00       47,082.00
                                 -------------------------------------------------------------------------------
    Total:......................  ..............  ..............  ..............  ..............       52,404.66
----------------------------------------------------------------------------------------------------------------

    The annual estimate of burden for subsequent years is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
           Instrument               respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Grantee Report..................              57               2             114           12.50        1,425.00
Client Report...................              57               2             114           24.00        2,736.00
                                 -------------------------------------------------------------------------------
    Total:......................  ..............  ..............  ..............  ..............        4,161.00
----------------------------------------------------------------------------------------------------------------

    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: September 26, 2011.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2011-25339 Filed 9-30-11; 8:45 am]
BILLING CODE 4165-15-P