36142 Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices 

A. Federal Reserve Bank of St. Louis 

(Holly A. Rieser, Manager) P.O. Box 442, 

St. Louis, Missouri 63166–2034. 

Comments can also be sent 

electronically to 

Comments.applications@stls.frb.org: 

1. John B. Allee, individually, and as 

trustee of the John B. Allee Heritage 

Trust, both of Tipton, Missouri; and Lori 

A. Woratzeck, as trustee of the Lori A. 

Woratzeck Heritage Trust, both of 

California, Missouri; to become 

members of the Allee Family Control 

Group, a group acting in concert, to 

retain voting shares of Latham 

Bancshares, Inc., and thereby indirectly 

retain voting shares of The Tipton 

Latham Bank, National Association, 

both of Tipton, Missouri. 

Board of Governors of the Federal Reserve 

System, July 2, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–14577 Filed 7–7–21; 8:45 am] 

BILLING CODE P 

GENERAL SERVICES 

ADMINISTRATION 

[Notice-PBS–2021–04; Docket No. 2020– 

0002; Sequence No. 14] 

Revised Notice of Intent/Revised 

Project Action and Notice of 

Availability for Land Ports of Entry 

(LPOE) 

AGENCY: Public Buildings Service (PBS), 

Pacific Rim Division, General Services 

Administration (GSA). 

ACTION: Notice. 

SUMMARY: GSA has prepared a Final 

Environmental Assessment (EA) and 

separate Finding of No Significant 

Impact (FONSI) which analyzed the 

potential impacts from the proposed 

construction of the Federal Motor 

Carrier Safety Administration (FMCSA) 

standalone bus inspection facility at the 

San Ysidro Land Port of Entry (LPOE) in 

San Diego, California. The two 

alternatives analyzed include: New 

‘‘Basic’’ Facility Buildout; No Build 

Action. GSA is advising the public that 

the Final EA and FONSI are available 

for public comment. 

DATES: Due to the COVID–19 pandemic 

and to ensure the safety of the public, 

a formal, in-person public meeting will 

not be held to solicit comments and 

provide information about the Final EA 

and FONSI. 

ADDRESSES: The Final EA can be viewed 

on the GSA website at www.gsa.gov/ 

r9fmcsa. In addition, copies may be 

obtained by calling or writing to the 

individual listed in this notice under 

the FOR FURTHER INFORMATION CONTACT

section. 

We will consider all comments that 

we receive on or before Monday, August 

9, 2021. You may submit comments by 

either of the following methods: 

• Electronic Mail: osmahn.kadri@

gsa.gov. 

• Postal Mail/Commercial Delivery: 

Send your comment to: Tina Sekula, 

JMT Inc., 1130 Situs Court, Suite 200, 

Raleigh, NC 27606. 

FOR FURTHER INFORMATION CONTACT: 

• Email: Osmahn Kadri at 

osmahn.kadri@gsa.gov. 

• Telephone: (415) 522–3617. 

• *NOTE* PLEASE DO NOT MAIL 

COMMENTS VIA THE U.S. POSTAL 

SERVICE (USPS) TO THE GSA 

MAILING ADDRESS AT THIS TIME. 

USPS MAIL CAN BE SENT TO JMT INC 

AT THE ADDRESS ABOVE. 

SUPPLEMENTARY INFORMATION: The Final 

EA and FONSI have been prepared to 

comply with the National 

Environmental Policy Act (NEPA) of 

1969, as amended (42 U.S. Code [U.S.C.] 

4321), as implemented by Council on 

Environmental Quality (CEQ) 

regulations (40 Code of Federal 

Regulations [CFR] 1500–1508), and 

policies of the GSA as the lead federal 

agency. The EA process provides steps 

and procedures to evaluate the potential 

social, economic, and environmental 

impacts from the construction of the 

proposed FMCSA Bus Inspection 

Facility at the San Ysidro LPOE while 

providing an opportunity for local, state, 

or federal agencies to provide input 

and/or comment through scoping, 

public information meetings, and/or a 

public hearing. The social, economic, 

and environmental considerations are 

evaluated and measured, as defined in 

the CEQ regulations, by their magnitude 

of impacts. 

The bus inspection station allows for 

FMCSA to conduct inspections of buses 

entering the United States from Mexico. 

FMCSA is required to conduct 

meaningful vehicle safety inspections 

and to accommodate vehicles placed out 

of service because of these inspections. 

The current bus inspection operations at 

the San Ysidro LPOE lacks the 

necessary infrastructure for bus 

inspections and is not adequate to 

maintain regular inspections. Therefore, 

the LPOE does not efficiently address 

safety needs for the travelling public, 

FMCSA staff, nor the capacity needs 

identified in future traffic projections at 

the LPOE. The lack of dedicated bus 

inspection infrastructure exposes 

FMCSA to safety risks while conducting 

inspections and is not in conformance 

with current FMCSA safety standards. 

GSA proposes to construct a new 

FMCSA Bus Inspection facility on a 1.5- 

acre parcel located north of the existing 

LPOE. 

A public scoping meeting on the 

project was held on June 18, 2019. 

Comments received during the meeting 

were considered by GSA in a Draft EA. 

The Draft EA was made available for 

public comment on May 15, 2020. 

Comments received during the onemonth comment period were considered 

by GSA in this Final EA. The FONSI, 

which is based on the Final EA, reflects 

the GSA’s determination that 

construction of the proposed facility 

will not have a significant impact on the 

quality of the human or natural 

environment. 

Russell Larson, 

Director, Portfolio Management Division, 

Pacific Rim Region, Public Buildings Service. 

[FR Doc. 2021–14510 Filed 7–7–21; 8:45 am] 

BILLING CODE 6820–YF–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2019–E–5322 and FDA– 

2019–E–5323] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PIQRAY 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for PIQRAY and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 7, 2021. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

January 4, 2022. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices 36143 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 7, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 7, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2019–E–5322 and FDA–2019–E–5323 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; PIQRAY.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with § 10.20 (21 

CFR 10.20) and other applicable 

disclosure law. For more information 

about FDA’s posting of comments to 

public dockets, see 80 FR 56469, 

September 18, 2015, or access the 

information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

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 human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, 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 human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, PIQRAY 

(alpelisib). PIQRAY is indicated in 

combination with fulvestrant for the 

treatment of postmenopausal women, 

and men, with hormone receptorpositive, human epidermal growth 

factor receptor 2-negative, PIK3CAmutated, advanced or metastatic breast 

cancer as detected by an FDA-approved 

test following progression on or after an 

endocrine-based regimen. Subsequent to 

this approval, the USPTO received 

patent term restoration applications for 

PIQRAY (U.S. Patent Nos. 8,277,462 and 

8,476,268) from Novartis AG and the 

USPTO requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

December 23, 2019, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of PIQRAY 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 


lotter on DSK11XQN23PROD with NOTICES1
36144 Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

PIQRAY is 3,264 days. Of this time, 

3,106 days occurred during the testing 

phase of the regulatory review period, 

while 158 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

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

355(i)) became effective: June 18, 2010. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 18, 2010. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 18, 2018. 

The applicant claims October 26, 2018, 

as the date the new drug application 

(NDA) for PIQRAY (NDA 212526) was 

initially submitted. However, FDA 

records indicate that NDA 212526 was 

submitted on December 18, 2018. 

3. The date the application was 

approved: May 24, 2019. FDA has 

verified the applicant’s claim that NDA 

212526 was approved on May 24, 2019. 

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 969 or 1,156 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 22, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14490 Filed 7–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on HIV/AIDS 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of a virtual meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Service is hereby giving notice that the 

Presidential Advisory Council on HIV/ 

AIDS (PACHA or the Council) will be 

holding the 71st full Council meeting 

utilizing virtual technology on Tuesday, 

August 3–Wednesday, August 4, 2021 

from 1:00–5:00 p.m. (ET) on both days. 

The meeting will be open to the public; 

a public comment session will be held 

during the meeting. Pre-registration is 

required to provide public comment 

during the meeting. To pre-register to 

attend or to provide public comment, 

please send an email to PACHA@

hhs.gov and include your name, 

organization, and title by close of 

business Monday, July 26, 2021. If you 

decide you would like to provide public 

comment but do not pre-register, you 

may submit your written statement by 

emailing PACHA@hhs.gov by close of 

business Wednesday, August 11, 2021. 

The meeting agenda will be posted on 

the PACHA page on HIV.gov at https:// 

www.hiv.gov/federal-response/pacha/ 

about-pacha prior to the meeting. 

DATES: The meeting will be held on 

Tuesday, August 3–Wednesday, August 

4, 2021 from 1:00–5:00 p.m. (ET) on 

both days. This meeting will be 

conducted utilizing virtual technology. 

ADDRESSES: Instructions on attending 

this meeting virtually will be posted one 

week prior to the meeting at: https://

www.hiv.gov/federal-response/pacha/ 

about-pacha. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Caroline Talev, MPA, Public Health 

Analyst, Presidential Advisory Council 

on HIV/AIDS, 330 C Street SW, Room 

L609A, Washington, DC 20024; (202) 

795–7622 or PACHA@hhs.gov. 

Additional information can be obtained 

by accessing the Council’s page on the 

HIV.gov site at www.hiv.gov/pacha. 

SUPPLEMENTARY INFORMATION: PACHA 

was established by Executive Order 

12963, dated June 14, 1995, as amended 

by Executive Order 13009, dated June 

14, 1996 and is currently operating 

under the authority given in Executive 

Order 13889, dated September 27, 2019. 

The Council was established to provide 

advice, information, and 

recommendations to the Secretary 

regarding programs and policies 

intended to promote effective 

prevention and care of HIV infection 

and AIDS. The functions of the Council 

are solely advisory in nature. 

The Council consists of not more than 

25 members. Council members are 

selected from prominent community 

leaders with particular expertise in, or 

knowledge of, matters concerning HIV 

and AIDS, public health, global health, 

philanthropy, marketing or business, as 

well as other national leaders held in 

high esteem from other sectors of 

society. Council members are appointed 

by the Secretary or designee, in 

consultation with the White House. 

Dated: June 9, 2021. 

Caroline Talev, 

Management Analyst, Office of Infectious 

Disease and HIV/AIDS Policy, Alternate 

Designated Federal Officer, Presidential 

Advisory Council on HIV/AIDS, Office of the 

Assistant Secretary for Health, Department 

of Health and Human Services. 

[FR Doc. 2021–14496 Filed 7–7–21; 8:45 am] 

BILLING CODE 4150–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 


lotter on DSK11XQN23PROD with NOTICES1