Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Shortage Designation Management System (SDMS), 17584-17585 [2023-05986]
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17584
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, TEGSEDI
(inotersen sodium) indicated for
treatment of the polyneuropathy of
hereditary transthyretin-mediated
amyloidosis in adults. Subsequent to
this approval, the USPTO received
patent term restoration applications for
TEGSEDI (U.S. Patent Nos. 8,101,743;
9,061,044; 9,399,774) from Ionis
Pharmaceuticals, Inc. and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In, letters dated
October 29, 2019, and November 29,
2019, FDA advised the USPTO that this
human drug product had undergone a
regulatory review period and that the
approval of TEGSEDI represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
TEGSEDI is 2,158 days. Of this time,
1,824 days occurred during the testing
phase of the regulatory review period,
while 334 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: November 9,
2012. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on November 9, 2012.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: November 6, 2017.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
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TEGSEDI (NDA 211172) was initially
submitted on November 6, 2017.
3. The date the application was
approved: October 5, 2018. FDA has
verified the applicant’s claim that NDA
211172 was approved on October 5,
2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 526 days or 1,246
days of patent term extension.
III. Petitions
Dated: March 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05906 Filed 3–22–23; 8:45 am]
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Health Resources and Services
Administration
[OMB No. 0906–0029—Extension]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Shortage
Designation Management System
(SDMS)
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
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
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 24, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the Acting HRSA
Information Collection Clearance
Officer, at paperwork@hrsa.gov or call
301–594–4394.
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—Extension.
Abstract: HRSA is committed to
improving the health of the nation’s
underserved communities 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
SUMMARY:
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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17585
Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
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
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. MUP designations are
limited to a 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 assessments 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 PCO,
state professional associations, etc. are
notified of each designation request
submitted via SDMS for their comments
and recommendations.
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 in the application—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.
HPSA scores, therefore, may and do
change from time to time. 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, so that
interested parties can access the
information.
A 60-day Notice was published in the
Federal Register, 88, FR pp. 360–361
(January 4, 2023). There were no public
comments.
Need and Proposed Use of the
Information: 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 the
HRSA Bureau of Health Workforce 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 detailed
information explaining how the area,
population, or facility faces a critical
shortage of health professionals.
Likely Respondents: State PCOs
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
ddrumheller on DSK120RN23PROD with NOTICES1
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
4
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
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19:23 Mar 22, 2023
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information to be collected; and (4) the
use of automated collection techniques
or other forms of information
PO 00000
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–05986 Filed 3–22–23; 8:45 am]
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]]>Agencies
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17584-17585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0906-0029--Extension]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Shortage
Designation Management System (SDMS)
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
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 24,
2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the Acting
HRSA Information Collection Clearance Officer, at [email protected] or
call 301-594-4394.
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--Extension.
Abstract: HRSA is committed to improving the health of the nation's
underserved communities 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
[[Page 17585]]
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 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. MUP designations are limited to a 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 assessments 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
PCO, state professional associations, etc. are notified of each
designation request submitted via SDMS for their comments and
recommendations.
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 in the application--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. HPSA scores, therefore, may and do change from time to
time. 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,
so that interested parties can access the information.
A 60-day Notice was published in the Federal Register, 88, FR pp.
360-361 (January 4, 2023). There were no public comments.
Need and Proposed Use of the Information: 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 the HRSA
Bureau of Health Workforce 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 detailed information
explaining how the area, population, or facility faces a critical
shortage of health professionals.
Likely Respondents: State PCOs 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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Designation Planning and 54 48 2,592 8 20,736
Preparation....................
SDMS Application................ 54 83 4,482 4 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. 2023-05986 Filed 3-22-23; 8:45 am]
BILLING CODE 4165-15-P
