Agency Information Collection Activities: Proposed Collection; Comment Request

CourtAgency For Healthcare Research And Quality,Health And Human Services Department
Citation87 FR 87
Publication Date03 January 2022
Record Number2021-28441
87
Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices
various revisions to CNMI’s primacy
program. For the revision covered by
this action, EPA promulgated the GWR
at 40 CFR subpart S on November 8,
2006 (71 FR 65574). The GWR provides
protection against microbial pathogens
in public water systems using ground
water sources. EPA has determined that
the GWR requirements were adopted
into the CNMI Commonwealth Register,
Section 2141 (alternatively published as
Northern Mariana Islands
Administrative Code, Title 65, Chapter
20) in a manner that CNMI’s regulations
are comparable to and no less stringent
than the federal requirements. EPA has
also determined that CNMI’s program
revision request meets all of the
regulatory requirements for approval, as
set forth in 40 CFR 142.12, including a
side-by-side comparison of the Federal
requirements demonstrating the
corresponding CNMI authorities,
additional materials to support special
primacy requirements of 40 CFR 142.16,
a review of the requirements contained
in 40 CFR 142.10 necessary for CNMI to
attain and retain primary enforcement
responsibility, and a statement by the
CNMI Attorney General certifying that
CNMI’s laws and regulations to carry
out the program revision were duly
adopted and are enforceable. The
Attorney General’s statement also
affirms that there are no environmental
audit privilege and immunity laws that
would impact CNMI’s ability to
implement or enforce the CNMI laws
and regulations pertaining to the
program revision. Therefore, EPA
approves this revision of CNMI’s
approved primacy program. The
Technical Support Document, which
provides EPA’s analysis of CNMI’s
program revision request, is available by
submitting a request to the following
email address: R9dw-program@epa.gov.
Please note ‘‘Technical Support
Document’’ in the subject line of the
email.
Public Process. Any interested person
may request a public hearing on this
determination. A request for a public
hearing must be received or postmarked
before February 2, 2022, and addressed
to the Regional Administrator of EPA
Region 9, via the following email
address: R9dw-program@epa.gov, or by
contacting the EPA Region 9 contact
person listed above in this notice by
telephone if you do not have access to
email. Please note, ‘‘State Program
Revision Determination’’ in the subject
line of the email. The Regional
Administrator may deny frivolous or
insubstantial requests for a hearing. If a
timely request for a public hearing is
made, then EPA Region 9 may hold a
public hearing. Any request for a public
hearing shall include the following
information: 1. The name, address, and
telephone number of the individual,
organization, or other entity requesting
a hearing; 2. A brief statement of the
requesting person’s interest in the
Regional Administrator’s determination
and of information that the requesting
person intends to submit at such
hearing; and 3. The signature of the
individual making the request, or, if the
request is made on behalf of an
organization or other entity, the
signature of a responsible official of the
organization or other entity.
If EPA Region 9 does not receive a
timely request for a hearing or a request
for a hearing was denied by the Regional
Administrator for being frivolous or
insubstantial, and the Regional
Administrator does not elect to hold a
hearing on their own motion, EPA’s
approval shall become final and
effective on February 2, 2022, and no
further public notice will be issued.
Authority: Section 1413 of the Safe
Drinking Water Act, as amended, 42
U.S.C. 300g–2 (1996), and 40 CFR part
142 of the National Primary Drinking
Water Regulations.
Dated: December 23, 2021.
Deborah Jordan,
Acting Regional Administrator, EPA Region
9.
[FR Doc. 2021–28330 Filed 12–30–21; 8:45 am]
BILLING CODE 6560–50–P
GENERAL SERVICES
ADMINISTRATION
[Notice–MA–2021–06; Docket No. 2021–
0002, Sequence No. 30]
Calendar Year (CY) 2022 Privately
Owned Vehicle (POV) Mileage
Reimbursement Rates; CY 2022
Standard Mileage Rate for Moving
Purposes
AGENCY
: Office of Government-Wide
Policy (OGP), General Services
Administration (GSA).
ACTION
: Notice.
SUMMARY
: GSA is updating the mileage
reimbursement rate for privately owned
automobiles (POA), airplanes, and
motorcycles as required by statute. This
information will be available in FTR
Bulletin 22–05, which can be found on
GSA’s website at https://gsa.gov/
ftrbulletins.
DATES
: Applicability date: This notice
applies to travel and relocation
performed on or after January 1, 2022
through December 31, 2022.
FOR FURTHER INFORMATION CONTACT
: For
clarification of content, please contact
Ms. Cheryl D. McClain-Barnes, Program
Analyst, Office of Government-wide
Policy, Office of Asset and
Transportation Management, at 202–
208–4334, or by email at travelpolicy@
gsa.gov. Please cite Notice of FTR
Bulletin 22–05.
SUPPLEMENTARY INFORMATION
: GSA is
required by statute to set the mileage
reimbursement rate for privately owned
automobiles (POA) as the single
standard mileage rate established by the
Internal Revenue Service (IRS). The IRS
mileage rate for medical or moving
purposes is used to determine the POA
rate when a Government-furnished
automobile is authorized and also
represents the privately owned vehicle
(POV) standard mileage reimbursement
rate for official relocation. Finally, GSA
conducts independent reviews of the
cost of travel and the operation of
privately owned airplanes and
motorcycles on an annual basis to
determine their corresponding mileage
reimbursement rates. These reviews
evaluate various factors, such as the cost
of fuel, depreciation of the original
vehicle cost, maintenance and
insurance, state and Federal taxes, and
consumer price index data. FTR
Bulletin 22–05 establishes and
announces the new CY 2022 POV
mileage reimbursement rates for official
temporary duty and relocation travel.
This notice is the only notification to
agencies of revisions to the POV mileage
rates for official travel and relocation, in
addition to the changes posted on GSA’s
website at https://gsa.gov/mileage.
Krystal J. Brumfield,
Associate Administrator, Office of
Government-Wide Policy.
[FR Doc. 2021–28450 Filed 12–30–21; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY
: Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION
: Notice.
SUMMARY
: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
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88
Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices
information collection project ‘‘Online
Application Order Form for Products
from the Healthcare Cost and Utilization
Project (HCUP).’’
DATES
: Comments on this notice must be
received by March 4, 2022.
ADDRESSES
: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT
:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION
:
Proposed Project
Online Application Order Form for
Products From the Healthcare Cost and
Utilization Project (HCUP).
The Healthcare Cost and Utilization
Project (HCUP, pronounced ‘‘H-Cup’’) is
a vital resource helping the Agency
achieve its research agenda, thereby
furthering its goal of improving the
delivery of health care in the United
States. HCUP is a family of health care
databases and related software tools and
products developed through a Federal-
State-Industry partnership and
sponsored by AHRQ. HCUP includes
the largest collection of longitudinal
hospital care data in the United States,
with all-payer, encounter-level
information beginning in 1988. The
HCUP databases are annual files that
contain anonymous information from
hospital discharge records for inpatient
care and certain components of
outpatient care, such as emergency care
and ambulatory surgeries. The project
currently releases eight types of
databases created for research use on a
broad range of health issues, including
cost and quality of health services,
medical practice patterns, access to
health care programs, and outcomes of
treatments at the national, State, and
local market levels. HCUP also produces
a large number of software tools to
enhance the use of administrative health
care data for research and public health
use. Software tools use information
available from a variety of sources to
create new data elements, often through
sophisticated algorithms, for use with
the HCUP databases.
HCUP’s objectives are to:
Create and enhance a powerful
source of national, state, and all-payer
health care data.
Produce a broad set of software
tools and products to facilitate the use
of HCUP and other administrative data.
Enrich a collaborative partnership
with statewide data organizations (that
voluntarily participate in the project)
aimed at increasing the quality and use
of health care data.
Conduct and translate research to
inform decision making and improve
health care delivery.
This project is being conducted by
AHRQ through its primary contractor
and subcontractor, IBM Watson Health
and Pantheon Software, pursuant to
AHRQ’s statutory authority to conduct
and support research on healthcare and
on systems for the delivery of such care,
including activities with respect to the
outcomes, cost, cost-effectiveness, and
use of health care services and access to
such services. 42 U.S.C. 299a(a)(3).
Method of Collection
The project currently creates eight
types of restricted access public release
databases and related files that are
released to authorized users under the
terms of the HCUP Data Use Agreement
(DUA). These HCUP databases and files
are used by researchers for a broad range
of health issues, including cost and
quality of health services, medical
practice patterns, access to health care
programs, and outcomes of treatments at
the national, State, and local market
levels.
HCUP achieves the restricted access
public release and tracking of the HCUP
databases through the Online
Application Form for HCUP Products
(https://www.distributor.hcup-
us.ahrq.gov/SpecialPages/
Shoppingcart.aspx). To access the eight
types of database, HCUP users are
required to complete the Online
Application Form for HCUP Products
which includes three components, the
application, HCUP DUA training
(https://www.hcup-us.ahrq.gov/DUA/
dua/index.html) and signing a HCUP
DUA. Users are required to sign one of
two DUAs: (1) Nationwide or (2) state
(hereafter referred to collectively as the
HCUP DUA) after they complete the
HCUP DUA training.
Information collected in the HCUP
Online Application Form process will
be used for two purposes only:
1. Business Transaction: In order to
deliver the HCUP databases to the
applicants, contact information is
necessary for shipping the data on disk
(or any other media used in the future)
and payment collection.
2. Enforcement of the HCUP Data Use
Agreement (DUA): The HCUP DUA
contains several restrictions on use of
the data. Most of these restrictions have
been put in place to safeguard the
privacy of individuals and
establishments represented in the data.
For example, data users can only use the
data for research, analysis, and aggregate
statistical reporting and are prohibited
from attempting to identify any persons
in the data. Contact information on
HCUP DUAs is retained in the event
that a violation of the HCUP DUA takes
place requiring legal remedy.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden associated with the
applicants’ time to order any of the
HCUP databases. An estimated 1,800
persons will order HCUP data annually.
Each of these persons will complete
Online Application Order Form for
HCUP products (30 minutes). The total
burden for the Online Application
Order Form is estimated to be 900 hours
annually.
Exhibit 2 shows the estimated
annualized cost burden associated with
the applicants’ time to order HCUP data.
The total cost burden is estimated to be
$39,879 annually.
E
XHIBIT
1—E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Form name Number of
respondents
Number of
responses per
respondent
Hours per
response Total
burden hours
Total for the HCUP Data Purchase Ordering Form ........................................ 1,800 1 30/60 900
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89
Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices
E
XHIBIT
2—E
STIMATED
A
NNUALIZED
C
OST
B
URDEN
Number of
respondents Total
burden hours
Average
hourly
wage rate *
Total cost
burden
Total ................................................................................................................. 1,800 900 $44.31 $39,879
*Based upon the mean of the average wages for Life Scientists, All Other (19–1099), National Compensation Survey: Occupational Employ-
ment Statistics, May 2020 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor
Statistics. https://www.bls.gov/oes/current/oes_nat.htm#19-0000.
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: December 28, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–28441 Filed 12–30–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration’s (FDA), Center for
Biologics Evaluation and Research
(CBER), Center for Drug Evaluation and
Research (CDER), Center for Devices and
Radiological Health (CDRH), and Center
for Tobacco Products (CTP) have
modified their organizational structures.
These new organizational structures
were approved by the Deputy Secretary
of Health and Human Services and
effective on November 24, 2021.
FOR FURTHER INFORMATION CONTACT
:
Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk
Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041
Powder Mill Road, Beltsville, MD
20705–4304, 301–796–3843.
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
revised to reflect the Food and Drug
Administration’s reorganizations of
CBER, CDER’s Office of Medical Policy
(OMP), Office of Prescription Drug
Promotion (OPDP), CDRH’s Office of
Product Evaluation and Quality, and
CTP’s Office of Compliance and
Enforcement and Office of Science.
This reorganization will help to
enhance these organization’s ability to
advance FDA’s mission and streamline
operations and support functions.
The Center for Biologics Evaluation
and Research’s organizational changes
in the Office of the Center Director (OD),
the Office of Management, and the
Office of Communications, Outreach,
and Development refocus functions that
support CBER’s product offices to better
support the expected growth in those
offices. The OD’s functions are
streamlined into those that require
intensive engagement from the Center
Director and have no other natural
home. Several responsibilities are
realigned or consolidated to leverage
synergies with other functions.
Harnessing the power of real-world
evidence is a priority in the FDA
Priority Framework, the 21st Century
Cures Act, and the PDUFA commitment
letter. The changes proposed to CBER’s
Office of Biostatistics and Epidemiology
(OBE) position the center to advance
real-world evidence priorities for
biologics.
The 21st Century Cures Act
established the Regenerative Medicine
Advanced Therapy (RMAT) designation
program, in Office of Tissues and
Advanced Therapies (OTAT), and called
on FDA to work to advance standards
development for regenerative medicine
products in order to support the
development, evaluation, and review of
regenerative medicine products. The
RMAT program has generated
tremendous industry interest, and CBER
has granted 129 RMAT designations
since program inception in December
2016.
One of FDA’s key priorities is
leveraging innovation to advance public
health goals by continually improving
the product development process and
strengthening FDA’s gold standard.
CBER’s portfolio of products is currently
seeing an unprecedented level of
innovation and growth. These
innovations range from the development
of new pathogen inactivation
technology that has the potential to
drastically improve how FDA promotes
blood safety, the explosion in
submissions for gene therapies that have
the potential to transform patients’ lives,
innovations in approaches to managing
serious food allergies, and advances in
manufacturing technology for vaccines.
The changes proposed in two of CBER’s
product offices: OTAT and the Office of
Blood Research and Review (OBRR)
along with the crosscutting functions in
OBE and Office of Compliance and
Biologics Quality are intended to ensure
CBER’s regulatory structures and
processes are prepared to respond to
innovation and development in the
industry while upholding FDA’s
standards for safety and effectiveness for
biological products. Establishing the
Office of Regulatory Operations will
help CBER support continued efficiency
and effectiveness in CBER’s regulatory
processes and provide strategic
direction as the Center works to
modernize its supporting information
technology (IT) infrastructure.
The Center for Drug Evaluation and
Research’s OMP, Office of Prescription
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