60-day Federal Register Notice

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.

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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

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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

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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

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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:

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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

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Total
burden
(in hours)

1

FOR FURTHER INFORMATION CONTACT:

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Average
burden per
response
(in hours)

Number of
responses per
respondent

5146

SUPPLEMENTARY INFORMATION:

Food and Drug Administration

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Number of
respondents

Type of respondents

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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–

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