Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices 87 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
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 FederalState-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.hcupus.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. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices 89 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

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 Employment 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 


khammond on DSKJM1Z7X2PROD with NOTICES