Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 1421 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Sec. 582 of the FD&C Act; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average time 

per response 

(in hours) 

Total hours 

Request renewals (Waivers Guidance, sec. III) .................. 1 1 1 16 16 

Total .............................................................................. ........................ ........................ ........................ ........................ 114,932 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL DISCLOSURE BURDEN 1

Sec. 582 of the FD&C Act; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total 

disclosures 

Average time 

per disclosure 

(in hours) 

Total hours 

Illegitimate product notifications to trading partners (Notifications Guidance, sec. III.B) ............................................ 500 310 155,000 8 1,240,000 

Illegitimate product notification terminations to trading partners (Notifications Guidance, sec. III) .............................. 500 310 155,000 4 620,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,860,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We have reorganized the information 

collection by respondent activity and 

clarified where information collection 

elements are discussed in the respective 

guidance documents. Based on 

illegitimate product notifications FDA 

has already received, we previously 

estimated a total of 250 respondents. 

However, we have considered industry 

feedback indicating that more 

notifications may be submitted based on 

stakeholder understanding of FDA’s 

recent clarification of stolen product in 

the ‘‘Definitions of Suspect Product and 

Illegitimate Product for Verification 

Obligations Under the Drug Supply 

Chain Security Act’’ draft guidance 

(June 2021; available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

definitions-suspect-product-andillegitimate-product-verificationobligations-under-drug-supply). As 

such, we have increased our number of 

estimated respondents to 500 and 

assume 40 percent are manufacturers 

(200), 50 percent are wholesale 

distributors (250), and 10 percent are 

pharmacies (50). Because 

manufacturers, repackagers, and 

wholesale distributors are collectively 

responsible for prescription drugs from 

the point of manufacturing through 

distribution in the drug supply chain, 

we continue to assume that these three 

trading partners submit most 

notifications of illegitimate products. 

In response to industry feedback, we 

have increased our estimate of the 

average time per response from 1 hour 

to 8 hours to more accurately reflect the 

burden respondents may incur in 

satisfying the information collection. 

We have otherwise retained the average 

burden per response for activities 

associated with consultations and 

waiver/exception/exemption requests. 

Finally, also based on public comment 

and industry feedback, we have 

increased our estimate of the average 

number of disclosures/notifications per 

respondent, as well as our assumption 

of the average time necessary for each 

disclosure notification, for an increase 

from 66,070 to 1,860,000 hours 

annually. 

As a result of these adjustments, our 

estimated burden for the information 

collection reflects a cumulative increase 

since the last OMB review and approval. 

We attribute this increase to a more 

recent evaluation of the information 

collection and informal 

communications with industry and 

other interested stakeholders regarding 

burden estimates. 

Dated: January 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00327 Filed 1–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Telehealth 

Resource Center Performance 

Measurement Tool, OMB No. 0915– 

0361—Extension 

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 March 14, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 


khammond on DSKJM1Z7X2PROD with NOTICES
1422 Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 

Information Collection Request Title: 

Telehealth Resource Center Performance 

Measurement Tool OMB No. 0915– 

0361—Extension 

Abstract: HRSA requests an extension 

of their Telehealth Resource Center 

Performance Measurement Tool. The 

Telehealth Resource Centers (TRC) 

deliver telehealth technical assistance. 

There are two types of HRSA TRC 

programs: 

• Two National Telehealth Resource 

Center Programs focus on policy 

and technology. 

• 12 Regional Telehealth Resource 

Center Programs host activities and 

provide resources to rural and 

underserved areas. 

The HRSA Telehealth Resource 

Centers: 

• Provide training and support 

• Publicize information and research 

findings 

• Support collaboration and 

partnerships 

• Promote effective partnerships 

• Promote the use of telehealth by 

providing health care information and 

education to the public and medical 

specialists. 

The TRCs share expertise through 

individual consults, training, webinars, 

conference presentations, and the web. 

Need and Proposed Use of the 

Information: In order to evaluate 

existing programs, data are submitted to 

HRSA’s Office for the Advancement of 

Telehealth (OAT) through HRSA’s 

Performance Improvement Management 

System (PIMS). The data are used to 

measure the effectiveness of the 

technical assistance (TA). There is one 

data reporting period each year; during 

these reporting periods, data are 

reported for the previous twelve months 

of activity. Programs have 

approximately six weeks to enter their 

data into the PIMS system during each 

annual reporting period. 

The instrument was developed with 

the following four goals in mind: 

1. Improving access to needed 

services, 

2. Reducing rural and underserved 

population practitioner isolation, 

3. Improving health system 

productivity and efficiency, and 

4. Improving patient outcomes. 

The TRCs currently report on existing 

performance data elements using PIMS. 

The performance measures are designed 

to assess how the TRC program is 

meeting its goals to: 

• Expand the availability of telehealth 

services in underserved communities; 

• Improve the quality, efficiency, and 

effectiveness of telehealth services; 

• Promote knowledge exchange and 

dissemination about efficient and 

effective telehealth practices and 

technology; and 

• Establish sustainable TA centers 

providing quality, unbiased TA for the 

development and expansion of effective 

and efficient telehealth services in 

underserved communities. 

Additionally, the PIMS tool allows 

OAT to: 

• Determine the value added from the 

TRC Cooperative Agreement; 

• Justify budget requests; 

• Collect uniform, consistent data 

which enables OAT to monitor 

programs; 

• Provide guidance to grantees on 

important indicators to track over time 

for their own internal program 

management; 

• Measure performance relative to the 

mission of OAT/HRSA as well as 

individual goals and objectives of the 

program; 

• Identify topics of interest for future 

special studies; and 

• Identify changes in health care 

needs within rural and underserved 

communities, allowing programs to shift 

focus in order to meet those needs. 

Likely Respondents: The likely 

respondents will be telehealth 

associations, telehealth providers, rural 

and underserved health providers, 

clinicians that deliver services via 

telehealth, technical assistance 

providers, research organizations and 

academic medical centers. 

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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Telehealth Resource Center Performance Measurement 

Tool ................................................................................... 14 42 588 0.07 41 

14 ........................ 588 ........................ 41 

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. 2022–00328 Filed 1–10–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–0478] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 


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