Agency Information Collection Activities: Proposed Collection: Public Comment Request, 18240-18241 [2015-07673]

Download as PDF 18240 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 1, 2011, to comment on the draft guidance. FDA received one comment on the draft guidance and that comment was considered as the guidance was finalized. Two of the questions and answers were revised, in addition to a few editorial changes made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated December 2, 2010. On July 1, 2008, the USP implemented a requirement for the control of residual solvents in drug products marketed in the United States. Once implemented, the requirement, USP General Chapter <467> Residual Solvents, became a statutory requirement under section 501(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(b)). This document answers questions regarding CVM’s implementation of USP <467> Residual Solvents. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Residual Solvents in Animal Drug Products; Questions and Answers.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. asabaliauskas on DSK5VPTVN1PROD with NOTICES III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032; the collections of information in section 512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB control number 0910–0669. IV. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 V. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: March 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–07632 Filed 4–2–15; 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 June 8, 2015. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10C–03, 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 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: Shortage Designation Management System OMB No. 0906–xxxx–New. SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Abstract: HRSA’s Bureau of Health Workforce (BHW) is committed to improving the health of the nation’s underserved communities and vulnerable populations by developing, implementing, evaluating, and refining programs that strengthen the nation’s health workforce. The Department of Health and Human Services relies on two federal shortage designations to identify and dedicate resources to areas and populations in greatest need of providers: Health Professional Shortage Area (HPSA) designations and Medically Underserved Area/Medically Underserved Population (MUA/P) designations. HPSA designations are geographic areas, population groups, and facilities that are experiencing a shortage of health professionals. MUA/ P designations are areas, or populations within areas, that are experiencing a shortage of health care services. MUAs are designated for the entire population of a particular geographic area. MUP designations are limited to particular groups of underserved people within an area. These designations are currently used in a number of departmental programs that provide both federal and state government grant/program benefits for communities, health care facilities, and providers. BHW has the responsibility for designating and dedesignating HPSAs and MUA/Ps on behalf of the Secretary. HPSA designations are required to be reviewed and updated regularly to reflect current data. Individual states— through their Primary Care Office (PCO)—have primary responsibility for initiating an application for a new or updated HPSA designation, or withdrawing HPSAs that no longer meet the designation criteria. HRSA reviews the application and makes the final determination on the HPSA designation. Requests come from the PCOs who have access to the online application and review system, Shortage Designation Management System (SDMS). Requests that come from other sources are referred to the PCOs for their review and concurrence. In addition, interested parties, including the Governor, the State Primary Care Association, and state professional associations are notified of each request submitted for their comments and recommendations. In order to obtain a federal shortage designation for an area, population, or facility, PCOs must submit a shortage designation application through SDMS for review and approval by BHW. Both the HPSA and MUA/P application request local, state, and national data on the population that is experiencing a shortage of health professionals and the number of health professionals relative E:\FR\FM\03APN1.SGM 03APN1 18241 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices to the population covered by the proposed designation. The information collected on the applications is used to determine which areas, populations, and facilities have shortages. The lists of designated HPSAs are annually published in the Federal Register. In addition, lists of HPSAs are updated on the HRSA Web site, https://www.hrsa.gov/shortage/, so that interested parties can access the information. Need and Proposed Use of the Information: The need and purpose of this information collection is to obtain information to designate HPSAs and MUA/Ps. The information obtained from the SDMS Application is used to determine which areas, populations, and facilities have critical shortages of health professionals. The SDMS HPSA application and SDMS MUA/P Application are used for these designation determinations. Applicants must submit a SDMS application to BHW to obtain a federal shortage designation. The application asks for local, state, and national data required to determine the applicant’s eligibility to obtain a federal shortage designation. In addition, applicants must enter in detailed information explaining how the area, population, or facility faces a critical shortage of health professionals. Likely Respondents: State Primary Care Offices interested in obtaining a primary care, dental, or mental HPSA designation or a MUA/P in their state. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information Number of respondents Form name Number of responses per respondent 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 Designation Planning and Preparation ................................ SDMS Application ................................................................ 54 54 1 23 54 1,242 4.25 1.75 229.50 2,173.50 Total .............................................................................. 54 — 1,296 — 2,403.00 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. 2015–07673 Filed 4–2–15; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK5VPTVN1PROD with NOTICES National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; UDALL Center Review. Date: April 22–23, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Lorien Hotel & Spa, 1600 King Street, Alexandria, VA 22314. Contact Person: Birgit Neuhuber, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, INDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496–3562, neuhuber@ninds.nih.gov. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: March 30 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–07627 Filed 4–2–15; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: HIV/AIDS Innovative Research Applications. Date: April 7, 2015. Time: 11:00 a.m. to 3:00 p.m.. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Mark P Rubert, Ph.D., Scientific Review Officer, Center for E:\FR\FM\03APN1.SGM 03APN1

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[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18240-18241]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07673]


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

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 June 8, 2015.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 10C-03, 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 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: Shortage Designation 
Management System OMB No. 0906-xxxx-New.
    Abstract: HRSA's Bureau of Health Workforce (BHW) is committed to 
improving the health of the nation's underserved communities and 
vulnerable populations by developing, implementing, evaluating, and 
refining programs that strengthen the nation's health workforce. The 
Department of Health and Human Services relies on two federal shortage 
designations to identify and dedicate resources to areas and 
populations in greatest need of providers: Health Professional Shortage 
Area (HPSA) designations and Medically Underserved Area/Medically 
Underserved Population (MUA/P) designations. HPSA designations are 
geographic areas, population groups, and facilities that are 
experiencing a shortage of health professionals. MUA/P designations are 
areas, or populations within areas, that are experiencing a shortage of 
health care services. MUAs are designated for the entire population of 
a particular geographic area. MUP designations are limited to 
particular groups of underserved people within an area. These 
designations are currently used in a number of departmental programs 
that provide both federal and state government grant/program benefits 
for communities, health care facilities, and providers. BHW has the 
responsibility for designating and de-designating HPSAs and MUA/Ps on 
behalf of the Secretary.
    HPSA designations are required to be reviewed and updated regularly 
to reflect current data. Individual states--through their Primary Care 
Office (PCO)--have primary responsibility for initiating an application 
for a new or updated HPSA designation, or withdrawing HPSAs that no 
longer meet the designation criteria. HRSA reviews the application and 
makes the final determination on the HPSA designation. Requests come 
from the PCOs who have access to the online application and review 
system, Shortage Designation Management System (SDMS). Requests that 
come from other sources are referred to the PCOs for their review and 
concurrence. In addition, interested parties, including the Governor, 
the State Primary Care Association, and state professional associations 
are notified of each request submitted for their comments and 
recommendations.
    In order to obtain a federal shortage designation for an area, 
population, or facility, PCOs must submit a shortage designation 
application through SDMS for review and approval by BHW. Both the HPSA 
and MUA/P application request local, state, and national data on the 
population that is experiencing a shortage of health professionals and 
the number of health professionals relative

[[Page 18241]]

to the population covered by the proposed designation. The information 
collected on the applications is used to determine which areas, 
populations, and facilities have shortages.
    The lists of designated HPSAs are annually published in the Federal 
Register. In addition, lists of HPSAs are updated on the HRSA Web site, 
 https://www.hrsa.gov/shortage/, so that interested parties can access 
the information.
    Need and Proposed Use of the Information: The need and purpose of 
this information collection is to obtain information to designate HPSAs 
and MUA/Ps. The information obtained from the SDMS Application is used 
to determine which areas, populations, and facilities have critical 
shortages of health professionals. The SDMS HPSA application and SDMS 
MUA/P Application are used for these designation determinations. 
Applicants must submit a SDMS application to BHW to obtain a federal 
shortage designation. The application asks for local, state, and 
national data required to determine the applicant's eligibility to 
obtain a federal shortage designation. In addition, applicants must 
enter in detailed information explaining how the area, population, or 
facility faces a critical shortage of health professionals.
    Likely Respondents: State Primary Care Offices interested in 
obtaining a primary care, dental, or mental HPSA designation or a MUA/P 
in their state.
    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:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Designation Planning and                      54               1              54            4.25          229.50
 Preparation....................
SDMS Application................              54              23           1,242            1.75        2,173.50
                                 -------------------------------------------------------------------------------
    Total.......................              54              --           1,296              --        2,403.00
----------------------------------------------------------------------------------------------------------------

    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. 2015-07673 Filed 4-2-15; 8:45 am]
 BILLING CODE 4165-15-P
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