Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38165 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13639 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0584] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Pilot Survey To 

Develop Standardized Reporting 

Forms for Federally Funded Public 

Health Projects 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by July 27, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 


jspears on DSK121TN23PROD with NOTICES1EN27JN22.005</GPH>
38166 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The title 

of this information collection is Pilot 

Survey to Develop Standardized 

Reporting Forms for Federally Funded 

Public Health Projects. Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Pilot Survey To Develop Standardized 

Reporting Forms for Federally Funded 

Public Health Projects 

OMB Control Number 0910–NEW 

This information collection supports 

federally funded public health projects 

administered by the Agency’s Office of 

Regulatory Affairs (ORA). As part of 

FDA’s efforts to protect the public 

health, we work collaboratively with 

State partners to enhance oversight of 

FDA-regulated products. Consistent 

with applicable regulations pertaining 

to federally funded programs, we 

currently collect information related to 

an awardee’s progress in completing 

agreed-upon performance metrics 3 to 4 

times a year during the reporting period. 

Respondents to the information 

collection are recipients of FDA-funded 

projects who submit required 

information to FDA in free text and 

narrative form via portable document 

format. To increase our efficiency in 

evaluating program effectiveness and 

return-on-investment (ROI)/return-onvalue (ROV) for the federally funded 

projects that we administer, we intend 

to develop and establish the use of 

digital forms that contain standardized 

questions to capture data elements 

necessary to measure/track ROI/ROV. 

We believe the use of standardized 

forms will reduce the time required by 

awardees in completing and submitting 

progress reports. 

As part of the pilot, respondents will 

complete an initial report and progress/ 

performance reports, which include 

data fields to identify the award project 

and contact person and directs specific 

questions to respondents regarding 

project and progress updates. Based on 

public feedback, we hope to revise the 

reports, tailoring for project specificity 

and purpose, to include, but not limited 

to, improvements, such as drop-down 

menu selections and potential common 

response indicators that will reduce 

time for respondents and allow us to 

more quickly process information and 

determine impacts at the Agency level. 

As information will be requested of 

actively funded projects, it may become 

necessary to request additional 

information for a particular project to 

complete the performance evaluation(s) 

in a timely manner. To ensure data is 

sufficient, on a case-by-case basis, FDA 

anticipates a need for followup 

questionnaire(s) to supplement the 

progress reports as instruments of 

collection are developed and fine-tuned 

through this effort. 

In the Federal Register of July 29, 

2021 (86 FR 40853), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Awardee activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Initial Report ......................................................................... 400 1 400 10 4,000 

Updated Reports .................................................................. 400 2 800 40 32,000 

Supplement or Followup Report (if applicable) ................... 100 1 100 10 1,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 37,000 

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

We estimate that 400 respondents will 

participate under this pilot project and 

will submit an average of 3 to 4 reports 

within a single budget year (table 1). To 

ensure adequate reporting will be 

achieved over the course of this pilot, 

the option for a supplement or followup 

report is included in the estimated 

reporting burden; however, the need for 

these reports will be determined on a 

case-by-case basis with the FDA project 

manager. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Awardee activity Number of 

recordkeepers 

Records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Records related to Initial Report ............................ 400 1 400 0.5 hour (30 minutes) .. 200 

Records related to Updated Reports ..................... 400 2 800 0.5 hour (30 minutes) .. 400 

Records related to Supplement or Followup Report (if applicable).100 1 100 0.5 hour (30 minutes) .. 50 

Total ................................................................ ........................ ........................ ........................ ..................................... 650 

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

Recordkeeping activities include 

storing and maintaining records related 

to submitting a request to participate in 

the project and compiling reports. 

Respondents should use current record 

retention capabilities for electronic or 

paper storage to achieve these activities. 

We assume it will take 0.5 hour/year to 

ensure the documents related to 

submitting a request to participate in the 

program are retained properly according 

to their existing recordkeeping policies, 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38167 

but no less than 3 years, as 

recommended by FDA (table 2). 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Awardee activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Coordination with partnering entities related to Initial Report ................................................................................... 300 2 600 8 4,800 

Coordination with partnering entities related to Updated 

Reports ............................................................................. 300 4 1,200 8 9,600 

Coordination with partnering entities related to Supplement 

or Followup Report (if applicable) .................................... 100 2 200 8 1,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 16,000 

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

For those pilot projects that involve a 

participant composed of partnering 

entities in the program, FDA is taking 

into consideration the time that 

partnering entities will spend 

coordinating with each other in a pilot 

project. We estimate that 300 

respondents will work with their 

respective partnering entities and the 

average number of partnering entities 

will be 2. We assume each respondent 

will spend 8 hours coordinating with 

each partnering entity on each response 

for this pilot. We estimate that seven 

respondents will need to coordinate 

with an average of two partnering 

entities to create updated reports and 

the final report to submit to FDA (table 

3). 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13642 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended by the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the 

issuance of priority review vouchers as 

well as the approval of products 

redeeming a priority review voucher. 

FDA has determined that the 

supplemental application for 

ULTOMIRIS (ravulizumab-cwvz), 

approved April 27, 2022, meets the 

redemption criteria. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under 

section 529 of the FD&C Act (21 U.S.C. 

360ff), which was added by FDASIA, 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

supplemental application for 

ULTOMIRIS (ravulizumab-cwvz), 

approved April 27, 2022, meets the 

redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasesPriorityVoucherProgram/

default.htm. For further information 

about ULTOMIRIS (ravulizumab-cwvz), 

approved April 27, 2022, go to the 

‘‘Drugs@FDA’’ website at http://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13628 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Tick-Borne Disease 

Working Group 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As required by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the Tick-Borne Disease Working 

Group (TBDWG) will hold a meeting. 

The meeting will be open to the public 

via webcast. For this meeting, the 

TBDWG will review the first draft of 

chapters for the report and further 

discuss plans for developing the next 

report to the HHS Secretary and 

Congress on federal tick-borne activities 

and research, taking into consideration 

the 2018 and 2020 report. The 2022 

report will address a wide range of 

topics related to tick-borne diseases, 

such as, surveillance, prevention, 

diagnosis, diagnostics, and treatment; 

identify advances made in research, as 

well as overlap and gaps in tick-borne 

disease research; and provide 

recommendations regarding any 

appropriate changes or improvements to 

such activities and research. 

DATES: The public can view the meeting 

online via webcast on July 19–20, 2022 

from approximately 9:00 a.m. to 5:00 

p.m. ET (times are tentative and subject 

to change) each day. The confirmed 

times and agenda items for the meeting 


jspears on DSK121TN23PROD with NOTICES1