Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Shortage Designation Management System, 11094-11095 [2020-03783]

Download as PDF 11094 Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices such as abdominal pain and distension. Finally, FDA considered additional available mitigations for the spread of uterine tissue. Since 2014, FDA has provided marketing authorization for LPM containment systems intended to isolate and contain tissue that is considered benign. These products have been shown, through bench testing and simulated use testing, to contain such tissue during morcellation. For these reasons, FDA is proposing in this draft guidance to update its recommendations, as originally described in the 2014 guidance document, concerning the content and format of certain labeling information for LPMs. Specifically, FDA is recommending that manufacturers incorporate into the labeling for these devices information providing greater specificity regarding the risks of use as it relates to age, information regarding the risk of spreading benign uterine tissue, and information regarding the use of LPM containment systems. FDA considered comments received on the final guidance document that appeared in the Federal Register of November 25, 2014 (79 FR 70193). FDA revised the guidance as appropriate in response to the comments. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Product Labeling for Laparoscopic Power Morcellators.’’ 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. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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. 3501–3521). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: 21 CFR part Topic 807, subpart E .............................................................................................................. 800, 801, and 809 ........................................................................................................ 803 ................................................................................................................................ Premarket notification ............................... Medical Device Labeling Regulations ...... Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Dated: February 20, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–03827 Filed 2–25–20; 8:45 am] BILLING CODE 4164–01–P 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. Comments on this ICR should be received no later than April 27, 2020. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Shortage Designation Management System Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the SUMMARY: VerDate Sep<11>2014 17:22 Feb 25, 2020 Jkt 250001 Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. ADDRESSES: Health Resources and Services Administration khammond on DSKJM1Z7X2PROD with NOTICES Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Product Labeling for Laparoscopic Power Morcellators’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400052 to identify the guidance you are requesting. 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 Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. FOR FURTHER INFORMATION CONTACT: 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. 0906–0029—Revision. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 OMB control No. 0910–0120 0910–0485 0910–0437 Abstract: HRSA’s Bureau of Health Workforce 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. HHS 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. The authorizing statute for the National Health Service Corps (NHSC) created HPSAs to fulfill the statutory requirement that NHSC personnel be directed to areas of greatest need. To further differentiate areas of greatest need, HRSA calculates a score for each HPSA. There are three categories of HPSAs based on health discipline: Primary care, dental health, and mental health. Scores range from 1 to 25 for E:\FR\FM\26FEN1.SGM 26FEN1 11095 Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices primary care and mental health and from 1 to 26 for dental, with higher scores indicating greater need. They are used to prioritize applications for NHSC Loan Repayment Program award funding, and determine service sites eligible to receive NHSC Scholarship and Students-to-Service participants. MUA/P designations are geographic areas, or population groups within geographic areas, that are experiencing a shortage of primary care health care services based on the Index of Medical Underservice. MUAs are designated for the entire population of a particular geographic area. MUA/P designations are limited to particular subset of the population within a geographic area. Both designations were created to aid the federal government in identifying areas with healthcare workforce shortages. As part of HRSA’s cooperative agreement with the State Primary Care Offices (PCOs), the State PCOs conduct needs assessment in their states, determine what areas are eligible for designations, and submit designation applications for HRSA review via the Shortage Designation Management System (SDMS). Requests that come from other sources are referred to the PCOs for their review, concurrence, and submission via SDMS. 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 HRSA. 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 to the population covered by the proposed designation. The information collected on the applications is used to determine which areas, populations, and facilities have qualifying shortages. In addition, interested parties, including the Governor, the State Primary Care Association, state professional associations, etc. are notified of each designation request submitted via SDMS for their comments and recommendations. Previously, PCOs were required to provide HRSA with Census, American Community Survey, and Centers for Disease Control and Prevention data specific to the intended geographic area for designation known as a rational service area. With the development of the SDMS, PCOs are no longer required to provide this information as it is automatically populated in the system when they select the service area for designation. HRSA reviews the HPSA applications submitted by the State PCOs, and—if they meet the designation eligibility criteria for the type of HPSA or MUA/ P the application is for—designates the HPSA or MUA/P on behalf of the Secretary. HPSAs are statutorily required to be annually reviewed and revised as necessary after initial designation to reflect current data. HPSAs scores, therefore, may and do change from time to time. Currently, MUA/Ps do not have a statutorily mandated review period. The lists of designated HPSAs are published annually in the Federal Register. In addition, lists of HPSAs are updated on the HRSA website, https:// data.hrsa.gov/tools/shortage-area, so that interested parties can access the information. Need and Proposed Use of the Information: In 2014, SDMS was launched to facilitate the collection of information needed 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 per PCO application submission. The SDMS HPSA application and SDMS MUA/P Application are used for these designation determinations. Applicants must submit a SDMS application to HRSA to obtain a federal shortage designation. The application asks for local, state, and national data required to determine the application’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 ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents khammond on DSKJM1Z7X2PROD with NOTICES Form name Number of responses per respondent Average burden per response (in hours) Total responses Total burden hours Designation Planning and Preparation ................................ SDMS Application ................................................................ 54 54 48 83 2,592 4,482 8.00 4.00 20,736 17,928 Total .............................................................................. 54 ........................ 7,074 ........................ 38,664 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 VerDate Sep<11>2014 17:22 Feb 25, 2020 Jkt 250001 technology to minimize the information collection burden. DEPARTMENT OF HEALTH AND HUMAN SERVICES Maria G. Button, Director, Executive Secretariat. [Document Identifier: OS–0990–0438–60D] [FR Doc. 2020–03783 Filed 2–25–20; 8:45 am] BILLING CODE 4165–15–P PO 00000 Agency Information Collection Request; 60-Day Public Comment Request AGENCY: Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM Office of the Secretary, HHS. 26FEN1

Agencies

[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11094-11095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: Shortage 
Designation Management System

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, 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 ICR should be received no later than April 27, 
2020.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 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 [email protected] or call Lisa Wright-
Solomon, 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. 0906-0029--Revision.
    Abstract: HRSA's Bureau of Health Workforce 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. HHS 
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. 
The authorizing statute for the National Health Service Corps (NHSC) 
created HPSAs to fulfill the statutory requirement that NHSC personnel 
be directed to areas of greatest need. To further differentiate areas 
of greatest need, HRSA calculates a score for each HPSA. There are 
three categories of HPSAs based on health discipline: Primary care, 
dental health, and mental health. Scores range from 1 to 25 for

[[Page 11095]]

primary care and mental health and from 1 to 26 for dental, with higher 
scores indicating greater need. They are used to prioritize 
applications for NHSC Loan Repayment Program award funding, and 
determine service sites eligible to receive NHSC Scholarship and 
Students-to-Service participants.
    MUA/P designations are geographic areas, or population groups 
within geographic areas, that are experiencing a shortage of primary 
care health care services based on the Index of Medical Underservice. 
MUAs are designated for the entire population of a particular 
geographic area. MUA/P designations are limited to particular subset of 
the population within a geographic area. Both designations were created 
to aid the federal government in identifying areas with healthcare 
workforce shortages.
    As part of HRSA's cooperative agreement with the State Primary Care 
Offices (PCOs), the State PCOs conduct needs assessment in their 
states, determine what areas are eligible for designations, and submit 
designation applications for HRSA review via the Shortage Designation 
Management System (SDMS). Requests that come from other sources are 
referred to the PCOs for their review, concurrence, and submission via 
SDMS. 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 HRSA. 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 to the population covered 
by the proposed designation. The information collected on the 
applications is used to determine which areas, populations, and 
facilities have qualifying shortages. In addition, interested parties, 
including the Governor, the State Primary Care Association, state 
professional associations, etc. are notified of each designation 
request submitted via SDMS for their comments and recommendations.
    Previously, PCOs were required to provide HRSA with Census, 
American Community Survey, and Centers for Disease Control and 
Prevention data specific to the intended geographic area for 
designation known as a rational service area. With the development of 
the SDMS, PCOs are no longer required to provide this information as it 
is automatically populated in the system when they select the service 
area for designation.
    HRSA reviews the HPSA applications submitted by the State PCOs, 
and--if they meet the designation eligibility criteria for the type of 
HPSA or MUA/P the application is for--designates the HPSA or MUA/P on 
behalf of the Secretary. HPSAs are statutorily required to be annually 
reviewed and revised as necessary after initial designation to reflect 
current data. HPSAs scores, therefore, may and do change from time to 
time. Currently, MUA/Ps do not have a statutorily mandated review 
period.
    The lists of designated HPSAs are published annually in the Federal 
Register. In addition, lists of HPSAs are updated on the HRSA website, 
https://data.hrsa.gov/tools/shortage-area, so that interested parties 
can access the information.
    Need and Proposed Use of the Information: In 2014, SDMS was 
launched to facilitate the collection of information needed 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 per PCO 
application submission. The SDMS HPSA application and SDMS MUA/P 
Application are used for these designation determinations. Applicants 
must submit a SDMS application to HRSA to obtain a federal shortage 
designation. The application asks for local, state, and national data 
required to determine the application'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 ICR 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)
----------------------------------------------------------------------------------------------------------------
Designation Planning and                      54              48           2,592            8.00          20,736
 Preparation....................
SDMS Application................              54              83           4,482            4.00          17,928
                                 -------------------------------------------------------------------------------
    Total.......................              54  ..............           7,074  ..............          38,664
----------------------------------------------------------------------------------------------------------------

    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.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-03783 Filed 2-25-20; 8:45 am]
BILLING CODE 4165-15-P