32936 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Solicitation for 

Applications for Medicare Prescription 

Drug Plan 2023 Contracts; Use: Coverage 

for the prescription drug benefit is 

provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates, 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. 

Collection of this information is 

mandated in Part D of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) in 

Subpart 3. The application requirements 

are codified in Subpart K of 42 CFR 423 

entitled ‘‘Application Procedures and 

Contracts with PDP Sponsors.’’ 

The information will be collected 

under the solicitation of proposals from 

PDP, MA–PD, Cost Plan, Program of All 

Inclusive Care for the Elderly (PACE), 

and EGWP applicants. The collected 

information will be used by CMS to: (1) 

Ensure that applicants meet CMS 

requirements for offering Part D plans 

(including network adequacy, 

contracting requirements, and 

compliance program requirements, as 

described in the application), (2) 

support the determination of contract 

awards. Form Number: CMS–10137 

(OMB control number: 0938–0936); 

Frequency: Yearly; Affected Public: 

Businesses or other for-profits, Not-forprofit institutions; Number of 

Respondents: 716; Total Annual 

Responses: 382; Total Annual Hours: 

1,716. (For policy questions regarding 

this collection contact Arianne 

Spaccarelli at 410–786–5715.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Collection of 

Prescription Drug Event Data From 

Contracted Part D Providers for 

Payment; Use: The PDE data is used in 

the Payment Reconciliation System to 

perform the annual Part D payment 

reconciliation, any PDE data within the 

Coverage Gap Phase of the Part D benefit 

is used for invoicing in the CGDP, and 

the data are part of the report provided 

to the Secretary of the Treasury for 

Section 9008. 

CMS has used PDE data to create 

summarized dashboards and tools, 

including the Medicare Part D Drug 

Spending Dashboard & Data, the Part D 

Manufacturer Rebate Summary Report, 

and the Medicare Part D Opioid 

Prescribing Mapping Tool. The data are 

also used in the Medicare Trustees 

Report. Due to the market sensitive 

nature of PDE data, external uses of the 

data are subject to significant 

limitations. However, CMS does analyze 

the data on a regular basis to determine 

drug cost and utilization patterns in 

order to inform programmatic patterns 

and to develop informed policy in the 

Part D program. 

The information users will be 

Pharmacy Benefit Managers (PBMs), 

third party administrators and 

pharmacies, and the PDPs, MA–PDs, 

Fallbacks and other plans that offer 

coverage of outpatient prescription 

drugs under the Medicare Part D benefit 

to Medicare beneficiaries. The 

statutorily required data is used 

primarily for payment and is used for 

claim validation as well as for other 

legislated functions such as quality 

monitoring, program integrity and 

oversight. Form Number: CMS–10174 

(OMB control number: 0938–0982); 

Frequency: Yearly; Affected Public: 

Businesses or other for-profits, Not-forprofit institutions; Number of 

Respondents: 739; Total Annual 

Responses: 1,499,238,090; Total Annual 

Hours: 2,998. (For policy questions 

regarding this collection contact Ivan 

Iveljic at 410–786–3312.) 

Dated: June 17, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–13194 Filed 6–22–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–E–1642] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; GIVLAARI 

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 GIVLAARI and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application 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 the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 23, 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 

December 20, 2021. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

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 August 23, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 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: 


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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 32937 

• 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 No. FDA– 

2020–E–1642for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; GIVLAARI.’’ 

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.gpo.gov/ 

fdsys/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, 240–420–7500. 

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 GIVLAARI 

(givosiran). GIVLAARI is indicated for 

the treatment of adults with acute 

hepatic porphyria. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

GIVLAARI (U.S. Patent No. 9,133,461) 

from Alnylam Pharmaceuticals, Inc., 

and the USPTO requested FDA’s 

assistance in determining the patent’s 

eligibility for patent term restoration. In 

a letter dated August 20, 2020, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of GIVLAARI 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 

GIVLAARI is 1,533 days. Of this time, 

1,363 days occurred during the testing 

phase of the regulatory review period, 

while 170 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: September 11, 

2015. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on September 11, 2015. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: June 4, 2019. The 

applicant claims November 15, 2018, as 

the date the new drug application 

(NDA) for GIVLAARI (NDA 212194) was 

initially submitted. However, FDA 

records indicate that NDA 212194 was 

submitted on June 4, 2019. 


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32938 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 

1 In the case of a determination by the Secretary 

of Defense, the Secretary of HHS shall determine 

within 45 calendar days of such determination, 

whether to make a declaration under section 

564(b)(1) of the FD&C Act, and, if appropriate, shall 

promptly make such a declaration. 

3. The date the application was 

approved: November 20, 2019. FDA has 

verified the applicant’s claim that NDA 

212194 was approved on November 20, 

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 application for patent extension, 

this applicant seeks 190 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 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13176 Filed 6–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1729] 

Authorization and Revocation of 

Emergency Use of Drugs During the 

COVID–19 Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the Authorization) 

for a drug for use during the COVID–19 

pandemic. FDA issued the 

Authorization under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

requested by B. Braun Melsungen AG. 

The Authorization contains, among 

other things, conditions on the 

emergency use of the authorized drug. 

The Authorization follows the February 

4, 2020, determination by the Secretary 

of HHS that there is a public health 

emergency that has a significant 

potential to affect national security or 

the health and security of United States 

citizens living abroad and that involves 

a novel (new) coronavirus. The virus is 

now named SARS–CoV–2, which causes 

the illness COVID–19. On the basis of 

such determination, the Secretary of 

HHS declared on March 27, 2020, that 

circumstances exist justifying the 

authorization of emergency use of drugs 

and biological products during the 

COVID–19 pandemic, pursuant to the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

FDA is also announcing the revocation 

of the Authorization issued to Eli Lilly 

and Company for bamlanivimab alone. 

FDA revoked this authorization on April 

16, 2021. Reprinted in this document is 

the issuance of the Authorization and 

the revocation, which include an 

explanation of the reasons for issuance 

or revocation. 

DATES: The Authorization for B. Braun 

Melsungen AG was effective as of March 

12, 2021 and the revocation for Eli Lilly 

and Company was effective as of April 

16, 2021. 

ADDRESSES: Submit written requests for 

single copies of the Authorization and/ 

or revocation to the Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4338, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request or include a fax number to 

which the Authorizations may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorizations. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

301–796–8510 (this is not a toll free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) allows FDA to 

strengthen the public health protections 

against biological, chemical, nuclear, 

and radiological agents. Among other 

things, section 564 of the FD&C Act 

allows FDA to authorize the use of an 

unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. 

II. Criteria for EUA Authorization 

Section 564(b)(1) of the FD&C Act 

provides that, before an EUA may be 

issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of the following grounds: (1) A 

determination by the Secretary of 

Homeland Security that there is a 

domestic emergency, or a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a biological, chemical, radiological, 

or nuclear agent or agents; (2) a 

determination by the Secretary of 

Defense that there is a military 

emergency, or a significant potential for 

a military emergency, involving a 

heightened risk to United States (U.S.) 

military forces, including personnel 

operating under the authority of title 10 

or title 50, United States Code, of attack 

with (i) a biological, chemical, 

radiological, or nuclear agent or agents; 

or (ii) an agent or agents that may cause, 

or are otherwise associated with, an 

imminently life-threatening and specific 

risk to U.S. military forces; 1 (3) a 

determination by the Secretary of HHS 

that there is a public health emergency, 

or a significant potential for a public 

health emergency, that affects, or has a 

significant potential to affect, national 

security or the health and security of 

U.S. citizens living abroad, and that 

involves a biological, chemical, 

radiological, or nuclear agent or agents, 

or a disease or condition that may be 

attributable to such agent or agents; or 

(4) the identification of a material threat 

by the Secretary of Homeland Security 

pursuant to section 319F–2 of the Public 

Health Service (PHS) Act (42 U.S.C. 

247d–6b) sufficient to affect national 

security or the health and security of 

U.S. citizens living abroad. 

Once the Secretary of HHS has 

declared that circumstances exist 

justifying an authorization under 


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