Proposed Data Collection Submitted for Public Comment and Recommendations, 14271-14272 [2022-05302]
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Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–05301 Filed 3–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–0765; Docket No. CDC–2022–
0032]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies to comment on proposed and/
or continuing information collections,
as required by the Paperwork Reduction
Act of 1995. This notice invites
comments on an information collection
titled, CDC’s Fellowship Management
System (FMS). CDC uses the
information collected to aid and
enhance the selection of fellowship
participants and host sites and to track
participant information that helps
strengthen the current, emerging, and
ever-changing public health workforce.
DATES: CDC must receive written
comments on or before May 13, 2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0032 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
regulations.gov.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT:
To
request more information on the
VerDate Sep<11>2014
17:51 Mar 11, 2022
Jkt 256001
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Data collection for fellowship
programs using CDC’s Fellowship
Management System (OMB Control No.
0920–0765, Exp. 3/31/2023)—
Revision—Center for Surveillance,
Education, and Laboratory Services
(CSELS), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Division of Scientific Education
and Professional Development (DSEPD/
CSELS) requests a three-year revision to
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
14271
continue the use of the CDC Fellowship
Management System (FMS) to collect
data under the approved OMB Control
Number (0920–0765). The mission of
DSEPD is to improve health outcomes
through a competent, sustainable, and
empowered public health workforce.
Professionals in public health,
epidemiology, medicine, economics,
information science, veterinary
medicine, nursing, public policy, and
other related professionals seek
opportunities, through CDC fellowships,
to broaden their knowledge and skills,
and to improve the science and practice
of public health. CDC fellows are
assigned to state, tribal, local, and
territorial public health agencies; federal
government agencies, including CDC
and Department of Health and Human
Services’ (HHS) operational divisions,
such as Centers for Medicare &
Medicaid Services; and to
nongovernmental organizations,
including academic institutions, tribal
organizations, and private public health
organizations.
CDC uses FMS to collect, process, and
manage data from nonfederal applicants
seeking training or public health
support services through CDC
fellowships. FMS is used to
electronically submit fellowship
applications, submit fellowship host site
proposals, track completion of
fellowship activities, and maintain
fellowship alumni directories online.
FMS is a flexible and robust electronic
information system standardized and
tailored for each CDC fellowship,
collecting only the minimum amount of
information needed. The system is
critical to streamlining data
management for CDC and reducing
burden for respondents. FMS is key to
CDC’s ability to protect the public’s
health by supporting training
opportunities that strengthen the public
health workforce.
The proposed Revision has two
purposes: (1) Increase the number of
likely respondents and (2) change the
software platform on which FMS
operates. The increase in likely
respondents is a result of increased
funding that will allow DSEPD to
expand many of the fellowships
managed through FMS. The change in
software platform will provide CDC
with an even more efficient, effective,
and secure electronic mechanism for
collecting, processing, and monitoring
fellowship information. The proposed
software platform is the Microsoft®
Power Platform® (Microsoft
Corporation, Cary, Washington).
Integration of the suite of Microsoft
tools for data management, analysis, and
visualization will allow CDC to access
E:\FR\FM\14MRN1.SGM
14MRN1
14272
Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices
fellowship data in real time; moreover,
data cleaning and manipulation do not
need to be done outside the system,
which will increase the security of these
data. These increased functionalities
will facilitate the enhanced use of
administrative data collections for
program improvement and evidence
building activities across CDC and other
federal agencies. The update to the
software platform will also make it
easier for additional fellowships to opt
in to use FMS, expanding the benefits
of the system to a broader set of CDC
programs. Finally, the platform change
should also enhance user experience.
This Revision does not propose
substantive changes to the nature or
extent of information collected from
respondents, and will allow all
respondents—fellowship applicants,
public health agencies hosting
fellowship participants, and fellowship
alumni—the continued use of FMS for
submission of electronic data with
increased efficiency and reduced
burdens.
The burden table reflects OMBapproved changes since 2020 and
anticipated growth in fellowships from
2022 onward. CDC requests approval for
an estimated total of 14,914 annual
burden hours. There is no cost to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Fellowship applicants ........................
FMS Fellowship Application Information Collection Instrument.
FMS Fellowship Application Information Collection Instrument.
FMS Host Site Information Collection Instrument.
FMS Activity Tracking Information
Collection Instrument.
FMS Alumni Tracking Information
Collection Instrument.
Reference Letter Writers ...................
Public Health Agency or Organization Staff.
Public Health Agency or Organization Staff.
Fellowship Alumni .............................
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–05302 Filed 3–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2021–P–0959]
Determination That MPI DMSA KIDNEY
REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that MPI DMSA
KIDNEY REAGENT (Technetium Tc99m Succimer Kit), Injectable, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for Technetium
Tc-99m Succimer Kit, Injectable, if all
other legal and regulatory requirements
are met.
SUMMARY:
VerDate Sep<11>2014
17:51 Mar 11, 2022
Jkt 256001
87/60
7,462
6842
1
15/60
1,711
960
1
75/60
1,200
555
2
30/60
555
6463
1
37/60
3,986
........................
........................
........................
14,914
Michelle Weiner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 240
402–0374, Michelle.Weiner@
fda.hhs.gov.
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) Has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
Frm 00036
Fmt 4703
Total
burden
(in hours)
1
FOR FURTHER INFORMATION CONTACT:
PO 00000
Average
burden per
response
(in hours)
Number of
responses per
respondent
5146
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
jspears on DSK121TN23PROD with NOTICES1
Number of
respondents
Type of respondents
Sfmt 4703
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
MPI DMSA KIDNEY REAGENT
(Technetium Tc-99m Succimer Kit),
Injectable, is the subject of NDA
N017944, held by GE Healthcare, and
initially approved on May 18, 1982. MPI
DMSA KIDNEY REAGENT is indicated
to be used as an aid in the scintigraphic
evaluation of renal parenchymal
disorders. MPI DMSA KIDNEY
REAGENT (Technetium Tc-99m
Succimer Kit), Injectable, is currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Hyman, Phelps, & McNamara, P.C.
submitted a citizen petition dated
August 27, 2021 (Docket No. FDA–
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14271-14272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-0765; Docket No. CDC-2022-0032]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies to comment on proposed and/or continuing information
collections, as required by the Paperwork Reduction Act of 1995. This
notice invites comments on an information collection titled, CDC's
Fellowship Management System (FMS). CDC uses the information collected
to aid and enhance the selection of fellowship participants and host
sites and to track participant information that helps strengthen the
current, emerging, and ever-changing public health workforce.
DATES: CDC must receive written comments on or before May 13, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0032 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to regulations.gov.
Please note: Submit all comments through the Federal
eRulemaking portal (regulations.gov) or by U.S. mail to the address
listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Data collection for fellowship programs using CDC's Fellowship
Management System (OMB Control No. 0920-0765, Exp. 3/31/2023)--
Revision--Center for Surveillance, Education, and Laboratory Services
(CSELS), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Scientific Education and Professional Development
(DSEPD/CSELS) requests a three-year revision to continue the use of the
CDC Fellowship Management System (FMS) to collect data under the
approved OMB Control Number (0920-0765). The mission of DSEPD is to
improve health outcomes through a competent, sustainable, and empowered
public health workforce. Professionals in public health, epidemiology,
medicine, economics, information science, veterinary medicine, nursing,
public policy, and other related professionals seek opportunities,
through CDC fellowships, to broaden their knowledge and skills, and to
improve the science and practice of public health. CDC fellows are
assigned to state, tribal, local, and territorial public health
agencies; federal government agencies, including CDC and Department of
Health and Human Services' (HHS) operational divisions, such as Centers
for Medicare & Medicaid Services; and to nongovernmental organizations,
including academic institutions, tribal organizations, and private
public health organizations.
CDC uses FMS to collect, process, and manage data from nonfederal
applicants seeking training or public health support services through
CDC fellowships. FMS is used to electronically submit fellowship
applications, submit fellowship host site proposals, track completion
of fellowship activities, and maintain fellowship alumni directories
online. FMS is a flexible and robust electronic information system
standardized and tailored for each CDC fellowship, collecting only the
minimum amount of information needed. The system is critical to
streamlining data management for CDC and reducing burden for
respondents. FMS is key to CDC's ability to protect the public's health
by supporting training opportunities that strengthen the public health
workforce.
The proposed Revision has two purposes: (1) Increase the number of
likely respondents and (2) change the software platform on which FMS
operates. The increase in likely respondents is a result of increased
funding that will allow DSEPD to expand many of the fellowships managed
through FMS. The change in software platform will provide CDC with an
even more efficient, effective, and secure electronic mechanism for
collecting, processing, and monitoring fellowship information. The
proposed software platform is the Microsoft[supreg] Power
Platform[supreg] (Microsoft Corporation, Cary, Washington). Integration
of the suite of Microsoft tools for data management, analysis, and
visualization will allow CDC to access
[[Page 14272]]
fellowship data in real time; moreover, data cleaning and manipulation
do not need to be done outside the system, which will increase the
security of these data. These increased functionalities will facilitate
the enhanced use of administrative data collections for program
improvement and evidence building activities across CDC and other
federal agencies. The update to the software platform will also make it
easier for additional fellowships to opt in to use FMS, expanding the
benefits of the system to a broader set of CDC programs. Finally, the
platform change should also enhance user experience. This Revision does
not propose substantive changes to the nature or extent of information
collected from respondents, and will allow all respondents--fellowship
applicants, public health agencies hosting fellowship participants, and
fellowship alumni--the continued use of FMS for submission of
electronic data with increased efficiency and reduced burdens.
The burden table reflects OMB-approved changes since 2020 and
anticipated growth in fellowships from 2022 onward. CDC requests
approval for an estimated total of 14,914 annual burden hours. There is
no cost to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Fellowship applicants......... FMS Fellowship 5146 1 87/60 7,462
Application
Information
Collection
Instrument.
Reference Letter Writers...... FMS Fellowship 6842 1 15/60 1,711
Application
Information
Collection
Instrument.
Public Health Agency or FMS Host Site 960 1 75/60 1,200
Organization Staff. Information
Collection
Instrument.
Public Health Agency or FMS Activity 555 2 30/60 555
Organization Staff. Tracking
Information
Collection
Instrument.
Fellowship Alumni............. FMS Alumni 6463 1 37/60 3,986
Tracking
Information
Collection
Instrument.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 14,914
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-05302 Filed 3-11-22; 8:45 am]
BILLING CODE 4163-18-P
