Agency Information Collection Activities: Proposed Collection: Public Comment Request, 30255-30256 [2015-12700]

Download as PDF Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices the Administration for Children and Families. 4730, Silver Spring, MD 20993–0002, 301–796–5850. Robert Sargis, Reports Clearance Officer. I. Background [FR Doc. 2015–12693 Filed 5–26–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled ‘‘Draft Guidance on Risperidone.’’ The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject. 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 27, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov.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. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:45 May 26, 2015 Jkt 235001 In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific bioequivalence (BE) recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of a second revision of draft BE recommendations for risperidone injection. FDA initially approved new drug application 021346 for Risperdal Consta Long-Acting Injection in October 2003. There are no approved ANDAs for this product. In February 2010, FDA issued a draft guidance for industry on BE recommendations for generic risperidone injection. In August 2013, we issued a revised draft guidance on the same subject. We are now issuing a second revision of the draft guidance for industry on BE recommendations for generic risperidone injection (Draft Guidance on Risperidone). In February 2011, Johnson & Johnson Pharmaceutical Research and Development, LLC, manufacturer of Risperdal Consta, the reference listed drug, submitted a citizen petition requesting that FDA require that any ANDA referencing Risperdal Consta meet certain requirements, including requirements related to demonstrating BE (Docket No. FDA–2011–P–0086). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the revised draft BE recommendations in responding to the petition. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the design of BE studies to support ANDAs for risperidone injection. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 30255 II. 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. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: May 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12847 Filed 5–26–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than July 27, 2015. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of SUMMARY: E:\FR\FM\27MYN1.SGM 27MYN1 30256 Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Medicare Rural Hospital Flexibility Grant Program Performance OMB No. 0915–0363–Rev. Abstract: The Medicare Rural Hospital Flexibility Program (Flex) is authorized by Section 1820 of the Social Security Act (42 U.S.C. 1395i–4), as amended. The purpose of Flex is engaging state designated entities in activities relating to planning and implementing rural health care plans and networks; designating facilities as Critical Access Hospitals (CAHs); providing support for CAHs for quality improvement, quality reporting, performance improvements, and benchmarking; and integrating rural emergency medical services (EMS). Specifically, the Flex program provides funding for states to support technical assistance activities in hospitals to improve the quality of health care provided by CAHs; improve the financial and operational outcomes of CAHs; improve the Community Health and Emergency Medical Service (EMS) Needs of CAHs; enhance the health of rural communities through community/population health improvement; improve identification and management of Time Critical Diagnoses (TCD) and engage EMS capacity and performance in Rural Communities; assist in the conversion of qualified small rural hospitals to CAH status; and support the financial and operational transition to value based models and health care transformation models in the health care system. State designated Flex Programs will act as a resource and focal point for these activities, ensuring residents in rural communities have access to high quality health care services. Measures and goals identified in the Flex program take into consideration existing measures and priorities HHS has set for hospitals, to avoid both conflict and duplication of efforts. Need and Proposed Use of the Information: For this program, performance measures were drafted to provide data useful to the Flex program and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 2010. These measures cover principal topic areas of interest to the Federal Office of Rural Health Policy (FORHP), including: (a) Quality reporting; (b) quality improvement interventions; (c) financial and operational improvement initiatives; (d) population health management; and (e) innovative care models. Several measures will be used Number of respondents Form name Number of responses per respondent for this program and will inform FORHP’s progress toward meeting the goals set in GPRA. Furthermore, obtaining this information is important for identifying and understanding programmatic improvement across program areas, as well as guiding future iterations of the Flex Program and prioritizing areas of need and support. Likely Respondents: Respondents will be the Flex Program coordinator for each state participating in the Flex Program. There are currently 45 states participating in the Flex Program. 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. Total Estimated Annualized burden hours: Total responses Average burden per response (in hours) Total burden hours 45 1 45 216 9,720 Total .............................................................................. mstockstill on DSK4VPTVN1PROD with NOTICES Medicare Rural Hospital Flexibility Grant Program ............. 45 1 45 216 9,720 HRSA specifically 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–12700 Filed 5–26–15; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 18:14 May 26, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Advisory Committee on Interdisciplinary, Community-Based Linkages; 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 Interdisciplinary, Community-Based Linkages (ACICBL). Dates and Times: June 17, 2015 (9:30 a.m.– 4:30 p.m.). Place: Webinar/Conference Call Format. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Status: The meeting will be open to the public. Purpose: The ACICBL provides advice and recommendations to the Secretary of the Department of Health and Human Services (Secretary) concerning policy, program development, and other matters of significance related to interdisciplinary, community-based training grant programs authorized under sections 750–759, title VII, part D of the Public Health Service Act, as amended by the Affordable Care Act. The following sections are included under this part: 751—Area Health Education Centers; 752—Continuing Education Support for Health Professionals Serving in Underserved Communities; 753—Geriatrics Workforce Enhancement; 754—Quentin N. Burdick Program for Rural Interdisciplinary Training; 755—Allied Health and Other Disciplines; 756—Mental and Behavioral Health Education and Training, and 759—Program for Education and Training in Pain Care. E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Pages 30255-30256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
no later than July 27, 2015.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of

[[Page 30256]]

the data collection plans and draft instruments, email 
paperwork@hrsa.gov or call the HRSA Information Collection Clearance 
Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Medicare Rural Hospital 
Flexibility Grant Program Performance OMB No. 0915-0363-Rev.
    Abstract: The Medicare Rural Hospital Flexibility Program (Flex) is 
authorized by Section 1820 of the Social Security Act (42 U.S.C. 1395i-
4), as amended. The purpose of Flex is engaging state designated 
entities in activities relating to planning and implementing rural 
health care plans and networks; designating facilities as Critical 
Access Hospitals (CAHs); providing support for CAHs for quality 
improvement, quality reporting, performance improvements, and 
benchmarking; and integrating rural emergency medical services (EMS).
    Specifically, the Flex program provides funding for states to 
support technical assistance activities in hospitals to improve the 
quality of health care provided by CAHs; improve the financial and 
operational outcomes of CAHs; improve the Community Health and 
Emergency Medical Service (EMS) Needs of CAHs; enhance the health of 
rural communities through community/population health improvement; 
improve identification and management of Time Critical Diagnoses (TCD) 
and engage EMS capacity and performance in Rural Communities; assist in 
the conversion of qualified small rural hospitals to CAH status; and 
support the financial and operational transition to value based models 
and health care transformation models in the health care system. State 
designated Flex Programs will act as a resource and focal point for 
these activities, ensuring residents in rural communities have access 
to high quality health care services. Measures and goals identified in 
the Flex program take into consideration existing measures and 
priorities HHS has set for hospitals, to avoid both conflict and 
duplication of efforts.
    Need and Proposed Use of the Information: For this program, 
performance measures were drafted to provide data useful to the Flex 
program and to enable HRSA to provide aggregate program data required 
by Congress under the Government Performance and Results Act (GPRA) of 
2010. These measures cover principal topic areas of interest to the 
Federal Office of Rural Health Policy (FORHP), including: (a) Quality 
reporting; (b) quality improvement interventions; (c) financial and 
operational improvement initiatives; (d) population health management; 
and (e) innovative care models. Several measures will be used for this 
program and will inform FORHP's progress toward meeting the goals set 
in GPRA. Furthermore, obtaining this information is important for 
identifying and understanding programmatic improvement across program 
areas, as well as guiding future iterations of the Flex Program and 
prioritizing areas of need and support.
    Likely Respondents: Respondents will be the Flex Program 
coordinator for each state participating in the Flex Program. There are 
currently 45 states participating in the Flex Program.
    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.
    Total Estimated Annualized burden hours:

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Medicare Rural Hospital                       45               1              45             216           9,720
 Flexibility Grant Program......
                                 -------------------------------------------------------------------------------
    Total.......................              45               1              45             216           9,720
----------------------------------------------------------------------------------------------------------------

    HRSA specifically 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.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-12700 Filed 5-26-15; 8:45 am]
BILLING CODE 4165-15-P