35808 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a medical device will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(3)(B). 

FDA has approved for marketing the 

medical device ZEPHYR 

ENDOBRONCHIAL VALVE IMPLANT. 

ZEPHYR ENDOBRONCHIAL VALVE 

IMPLANT is indicated for the 

bronchoscopic treatment of adult 

patients with hyperinflation associated 

with severe emphysema in regions of 

the lung that have little to no collateral 

ventilation. Subsequent to this approval, 

the USPTO received patent term 

restoration applications for ZEPHYR 

ENDOBRONCHIAL VALVE IMPLANT 

(U.S. Patent Nos. 6,527,761 and 

7,798,147) from Pulmonx Corp., and the 

USPTO requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

October 29, 2019, FDA advised the 

USPTO that this medical device had 

undergone a regulatory review period 

and that the approval of ZEPHYR 

ENDOBRONCHIAL VALVE IMPLANT 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

ZEPHYR ENDOBRONCHIAL VALVE 

IMPLANT is 5,744 days. Of this time, 

5,565 days occurred during the testing 

phase of the regulatory review period, 

while 179 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(g)) involving this device became 

effective: October 9, 2002. The applicant 

claims that the investigational device 

exemption (IDE) required under section 

520(g) of the FD&C Act for human tests 

to begin became effective on March 11, 

2005. However, FDA records indicate 

that the IDE was determined 

substantially complete for clinical 

studies to have begun on October 9, 

2002, which represents the IDE effective 

date. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): January 2, 2018. 

The applicant claims December 29, 

2017, as the date the premarket approval 

application (PMA) for ZEPHYR 

ENDOBRONCHIAL VALVE IMPLANT 

(PMA 180002) was initially submitted. 

However, FDA records indicate that 

PMA 180002 was submitted on January 

2, 2018. 

3. The date the application was 

approved: June 29, 2018. FDA has 

verified the applicant’s claim that PMA 

180002 was approved on June 29, 2018. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 5 years or 1,510 

days of patent term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14482 Filed 7–6–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Lists of Designated Primary Medical 

Care, Mental Health, and Dental Health 

Professional Shortage Areas 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice informs the public 

of the availability of the complete lists 

of all geographic areas, population 

groups, and facilities designated as 

primary medical care, dental health, and 

mental health professional shortage 

areas (HPSAs) as of April 30, 2021. The 

lists are available on the shortage area 

topic page on HRSA’s data.hrsa.gov 

website. 

ADDRESSES: Complete lists of HPSAs 

designated as of April 30, 2021, are 

available on the website at https://

data.hrsa.gov/topics/health-workforce/ 

shortage-areas. Frequently updated 

information on HPSAs is available at 

https://data.hrsa.gov/tools/shortagearea. Information on shortage 

designations is available at https://

bhw.hrsa.gov/workforce-shortage-areas/ 

shortage-designation. 

FOR FURTHER INFORMATION CONTACT: For 

further information on the HPSA 

designations listed on the website or to 

request additional designation, 

withdrawal, or reapplication for 

designation, please contact Janelle D. 

McCutchen, DHEd, MPH, CHES, Chief, 

Shortage Designation Branch, Division 

of Policy and Shortage Designation, 

Bureau of Health Workforce (BHW), 

HRSA, 5600 Fishers Lane, Room 

11W14, Rockville, Maryland 20857, 

sdb@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 35809 

Background 

Section 332 of the Public Health 

Service (PHS) Act, 42 U.S.C. 254e, 

provides that the Secretary shall 

designate HPSAs based on criteria 

established by regulation. HPSAs are 

defined in section 332 to include (1) 

urban and rural geographic areas with 

shortages of health professionals, (2) 

population groups with such shortages, 

and (3) facilities with such shortages. 

Section 332 further requires that the 

Secretary annually publish lists of the 

designated geographic areas, population 

groups, and facilities. The lists of 

HPSAs are to be reviewed at least 

annually and revised as necessary. 

Final regulations (42 CFR part 5) were 

published in 1980 that include the 

criteria for designating HPSAs. Criteria 

were defined for seven health 

professional types: Primary medical 

care, dental, psychiatric, vision care, 

podiatric, pharmacy, and veterinary 

care. The criteria for correctional facility 

HPSAs were revised and published on 

March 2, 1989 (54 FR 8735). The criteria 

for psychiatric HPSAs were expanded to 

mental health HPSAs on January 22, 

1992 (57 FR 2473). Currently funded 

PHS Act programs use only the primary 

medical care, mental health, or dental 

HPSA designations. 

HPSA designation offers access to 

potential federal assistance. Public or 

private nonprofit entities are eligible to 

apply for assignment of National Health 

Service Corps (NHSC) personnel to 

provide primary medical care, mental 

health, or dental health services in or to 

these HPSAs. NHSC health 

professionals enter into service 

agreements to serve in federally 

designated HPSAs. Entities with clinical 

training sites located in HPSAs are 

eligible to receive priority for certain 

residency training program grants 

administered by HRSA’s BHW. Other 

federal programs also utilize HPSA 

designations. For example, under 

authorities administered by the Centers 

for Medicare and Medicaid Services, 

certain qualified providers in 

geographic area HPSAs are eligible for 

increased levels of Medicare 

reimbursement. 

Content and Format of Lists 

The three lists of designated HPSAs 

are available on the HRSA Data 

Warehouse shortage area topic web page 

and include a snapshot of all geographic 

areas, population groups, and facilities 

that were designated HPSAs as of April 

30, 2021. This notice incorporates the 

most recent annual reviews of 

designated HPSAs and supersedes the 

HPSA lists published in the Federal 

Register on June 15, 2020 (Federal 

Register/Vol. 85, No. 115/Monday, June 

15, 2020/Notices 36219). 

In addition, all Indian Tribes that 

meet the definition of such Tribes in the 

Indian Health Care Improvement Act of 

1976, 25 U.S.C. 1603, are automatically 

designated as population groups with 

primary medical care and dental health 

professional shortages. Further, the 

Health Care Safety Net Amendments of 

2002 provides eligibility for automatic 

facility HPSA designations for all 

federally qualified health centers 

(FQHCs) and rural health clinics that 

offer services regardless of ability to 

pay. Specifically, these entities include 

FQHCs funded under section 330 of the 

PHS Act, FQHC Look-Alikes, and Tribal 

and urban Indian clinics operating 

under the Indian Self-Determination 

and Education Act of 1975 (25 U.S.C. 

450) or the Indian Health Care 

Improvement Act. Many, but not all, of 

these entities are included on this 

listing. Absence from this list does not 

exclude them from HPSA designation; 

facilities eligible for automatic 

designation are included in the database 

when they are identified. 

Each list of designated HPSAs is 

arranged by state. Within each state, the 

list is presented by county. If only a 

portion (or portions) of a county is (are) 

designated, a county is part of a larger 

designated service area, or a population 

group residing in a county or a facility 

located in the county has been 

designated, the name of the service area, 

population group, or facility involved is 

listed under the county name. A county 

that has a whole county geographic or 

population group HPSA is indicated by 

the phrase ‘‘County’’ following the 

county name. 

Development of the Designation and 

Withdrawal Lists 

Requests for designation or 

withdrawal of a particular geographic 

area, population group, or facility as a 

HPSA are received continuously by 

BHW. Under a Cooperative Agreement 

between HRSA and the 54 state and 

territorial Primary Care Offices (PCOs), 

PCOs conduct needs assessments and 

submit applications to HRSA to 

designate areas as HPSAs. BHW refers 

requests that come from other sources to 

PCOs for review. In addition, interested 

parties, including Governors, State 

Primary Care Associations, and state 

professional associations, are notified of 

requests so that they may submit their 

comments and recommendations. 

BHW reviews each recommendation 

for possible addition, continuation, 

revision, or withdrawal. Following 

review, BHW notifies the appropriate 

agency, individuals, and interested 

organizations of each designation of a 

HPSA, rejection of recommendation for 

HPSA designation, revision of a HPSA 

designation, and/or advance notice of 

pending withdrawals from the HPSA 

list. Designations (or revisions of 

designations) are effective as of the date 

on the notification from BHW and are 

updated daily on the HRSA Data 

Warehouse Find Shortage Area website. 

The effective date of a withdrawal will 

be the next publication of a notice 

regarding the list of designated HPSAs 

in the Federal Register. 

Diana Espinosa, 

Acting Administrator. 

[FR Doc. 2021–14408 Filed 7–6–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: The Maternal, 

Infant, and Early Childhood Home 

Visiting Program Quarterly 

Performance Report, OMB No. 0906– 

0016, Revision 

AGENCY: Health Resources and Service’s 

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 September 7, 

2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, 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 Lisa Wright-Solomon, the HRSA 


khammond on DSKJM1Z7X2PROD with NOTICES