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 


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38168 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 

will be posted on the TBDWG web page 

at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 

2022-07-19/index.html when this 

information becomes available. 

FOR FURTHER INFORMATION CONTACT: 

James Berger, Designated Federal Officer 

for the TBDWG; Office of Infectious 

Disease and HIV/AIDS Policy, Office of 

the Assistant Secretary for Health, 

Department of Health and Human 

Services, Mary E. Switzer Building, 330 

C Street SW, Suite L600, Washington, 

DC 20024. Email: tickbornedisease@

hhs.gov. Phone: 202–795–7608. 

SUPPLEMENTARY INFORMATION: A link to 

view the webcast can be found on the 

meeting website at https://www.hhs.gov/ 

ash/advisory-committees/ 

tickbornedisease/meetings/2022-07-19/ 

index.html when it becomes available. 

The public will have an opportunity to 

present their views to the TBDWG orally 

during the meeting’s public comment 

session or by submitting a written 

public comment. Comments should be 

pertinent to the meeting discussion. 

Persons who wish to provide verbal or 

written public comment should review 

instructions at https://www.hhs.gov/ 

ash/advisory-committees/ 

tickbornedisease/meetings/2022-07-19/ 

index.html and respond by midnight 

July 11, 2022 ET. Verbal comments will 

be limited to three minutes each to 

accommodate as many speakers as 

possible during the 30-minute session. 

Written public comments will be 

accessible to the public on the TBDWG 

web page prior to the meeting. 

Background and Authority: The TickBorne Disease Working Group was 

established on August 10, 2017, in 

accordance with Section 2062 of the 

21st Century Cures Act, and the Federal 

Advisory Committee Act, 5 U.S.C. App., 

as amended, to provide expertise and 

review federal efforts related to all tickborne diseases, to help ensure 

interagency coordination and minimize 

overlap, and to examine research 

priorities. The TBDWG is required to 

submit a report to the HHS Secretary 

and Congress on their findings and any 

recommendations for the federal 

response to tick-borne disease every two 

years. 

Dated: June 7, 2022. 

James J. Berger, 

Designated Federal Officer, Tick-Borne 

Disease Working Group, Office of Infectious 

Disease and HIV/AIDS Policy. 

[FR Doc. 2022–13575 Filed 6–24–22; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information (RFI): HHS 

Initiative To Strengthen Primary Health 

Care 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of Request for 

Information. 

SUMMARY: U.S. Department of Health 

and Human Services (HHS) Office of the 

Assistant Secretary for Health (OASH) 

requests input from persons, 

communities, health care providers, 

purchasers and payers, educators, 

researchers, and other members of the 

public about what the federal 

government could do to strengthen 

primary health care in the United States. 

Improving access to health care, 

advancing health equity, and improving 

the health of the Nation are top 

priorities for the Biden-Harris 

Administration and HHS. Access to 

high-quality primary health care has 

been shown to improve health equity 

and health outcomes, and is essential 

for addressing key priorities, including: 

the COVID–19 pandemic; mental and 

substance use disorder prevention and 

care, including suicide and overdose 

prevention; prevention and management 

of chronic conditions; gender-based 

violence; and maternal and child health 

and well-being. However, our nation’s 

primary health care foundation is 

weakening and in need of support: 

primary health care is under-resourced; 

the workforce is shrinking; workforce 

well-being is in peril; and many 

practices face reimbursement challenges 

that may result in financial instability. 

The HHS Initiative to Strengthen 

Primary Health Care (the Initiative) aims 

to establish a federal foundation for the 

provision of primary health care for all 

that supports improved health outcomes 

and advanced health equity. The first 

task is to develop an initial HHS plan 

for strengthening primary health care 

that will delineate specific actions that 

HHS agencies and offices may take to 

achieve the aims, within the current 

legislation and funding environment. In 

addition, the plan will include actions 

that establish an infrastructure in HHS 

to continue its focus on strengthening 

primary health, developing subsequent 

HHS plans that build on the initial plan, 

and monitoring progress and impact. 

The purpose of this RFI is to provide 

OASH with diverse perspectives, 

experiences, and knowledge that may 

inform the development of the initial 

plan for HHS, as well as future steps for 

the Initiative. OASH seeks information 

about successful approaches and 

innovations that improve primary 

health care payment, delivery models, 

service integration, access, workforce 

education, training and well-being, 

digital health and primary care 

measurement and research. OASH also 

seeks information about barriers to 

implementation of such innovations and 

how they could be overcome, including 

specific ideas for possible HHS action. 

OASH encourages respondents to 

address health equity, and is 

particularly interested in information 

from community-based settings, such as 

public housing, personal homes, group 

homes, and assisted living facilities 

where older adults and people with 

disabilities may live, and about 

populations traditionally underserved 

by current primary health care. 

DATES: To be assured consideration, 

comments must be received at the email 

address provided below, no later than 

11:59 p.m. Eastern Time (ET) on August 

1, 2022. HHS will not reply individually 

to responders but will consider all 

comments submitted by the deadline. 

ADDRESSES: Please submit all responses 

via email to OASHPrimaryHealthCare@

hhs.gov as a Word document attachment 

or in the body of an email. Include 

‘‘Primary Health Care RFI’’ in the 

subject line of the email. 

FOR FURTHER INFORMATION CONTACT: For 

additional information, direct questions 

to the OASH Primary Health Care Team 

at OASHPrimaryHealthCare@hhs.gov or 

Sarah Boateng at (202) 401–7003. 

SUPPLEMENTARY INFORMATION: 

Instructions: Response to this RFI is 

voluntary. Each responding entity 

(person or organization) is requested to 

submit only one response. OASH 

welcomes responses to inform policies 

and actions to strengthen primary health 

care. Respond to one or as many 

prompts as you choose. Be concise with 

your submissions, which must not 

exceed four pages in 12-point or larger 

font, with a page number provided on 

each page. Responses should include 

the name of the person(s) or 

organization(s) filing the comment. 

OASH invites input from members of 

the public representing all backgrounds 

and perspectives. In particular, OASH is 

interested in input from individuals; 

paid and unpaid caregivers; 

communities; community-based 

organizations; health care providers 

(please state discipline and specialty, as 

appropriate); professional societies; 

community health centers and Rural 

Health Clinics; state, local, tribal, and 

territorial governments and public 


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