36286 Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product AJOVY 

(fremanezumab-vfrm). AJOVY is 

indicated for the preventive treatment of 

migraine in adults. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for AJOVY 

(U.S. Patent No. 8,007,794) from Teva 

Pharmaceuticals International GmbH, 

and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated July 14, 2020, FDA 

advised the USPTO that this human 

biological product had undergone a 

regulatory review period and that the 

approval of AJOVY 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 

AJOVY is 3,216 days. Of this time, 2,882 

days occurred during the testing phase 

of the regulatory review period, while 

334 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 (21 U.S.C. 355(i)) 

became effective: November 26, 2009. 

The applicant claims November 19, 

2009, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was November 26, 

2009, which was 30 days after FDA 

receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): October 16, 2017. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

AJOVY (BLA 761089) was initially 

submitted on October 16, 2017. 

3. The date the application was 

approved: September 14, 2018. FDA has 

verified the applicant’s claim that BLA 

761089 was approved on September 14, 

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 application for patent extension, 

this applicant seeks 1,454 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: July 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14652 Filed 7–8–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Neurodevelopmental and Neurological 

Disorders. 

Date: August 3, 2021. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Samuel C. Edwards, Ph.D., 

Chief, BDCN IRG, Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 5210, MSC 7846, 

Bethesda, MD 20892, (301) 435–1246, 

edwardss@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Eye Disease and Infections. 

Date: August 5, 2021. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Alessandra C. Rovescalli, 

Ph.D., Scientific Review Officer, National 

Institutes of Health, Center for Scientific 

Review, 6701 Rockledge Drive, Rm 5205, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1021, rovescaa@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Cognitive and Neuropathological 

Signatures of Alzheimer’s Disease, Brain 

Injury and Aging. 

Date: August 5, 2021. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Samuel C. Edwards, Ph.D., 

Chief, BDCN IRG, Center for Scientific 

Review, National Institutes of Health, 6701 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices 36287 

Rockledge Drive, Room 5210, MSC 7846, 

Bethesda, MD 20892, (301) 435–1246, 

edwardss@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: July 2, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–14617 Filed 7–8–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 30-Day Comment 

Request: Generic Clearance To Collect 

Stakeholder Feedback on the Research 

Domain Criteria (RDoC) Initiative, 

(NIMH) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30 days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Andrew Hooper, 

NIMH Project Clearance Liaison, 

Science Policy and Evaluation Branch, 

Office of Science Policy, Planning and 

Communications, NIMH, Neuroscience 

Center, 6001 Executive Boulevard, MSC 

9667, Bethesda, Maryland 20892, call 

(301) 480–8433, or email your request, 

including your mailing address, to 

nimhprapubliccomments@mail.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on May 5, 2021, pages 23974– 

23975 (Vol. 86, No. 85) and allowed 60 

days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Institute of Mental Health 

(NIMH), National Institutes of Health, 

may not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

Proposed Collection Title: Generic 

Clearance to Collect Stakeholder 

Feedback on the Research Domain 

Criteria (RDoC) Initiative, 0925–0756, 

EXTENSION, exp., date 07/31/2021, 

National Institute of Mental Health 

(NIMH), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: This request serves as notice 

that the National Institute of Mental 

Health (NIMH) plans to collect 

stakeholder feedback to assess the 

strengths and weaknesses of the 

Research Domain Criteria (RDoC) 

initiative. NIMH launched RDoC in 

2009 to implement Strategy 1.4 of the 

2008 NIMH Strategic Plan: ‘‘Develop 

new ways of classifying disorders based 

on dimensions of observable behaviors 

and brain functions.’’ Rather than 

beginning with a syndrome and then 

working ‘‘down’’ to clarify mechanisms, 

the aim of RDoC is to guide research 

that begins with disruptions in 

neurobiological and behavioral 

mechanisms, and then works across 

systems to clarify connections among 

such disruptions and clinical 

symptoms. NIMH has developed social 

media platforms and tools for the RDoC 

initiative, including a dedicated RDoC 

twitter account (https://twitter.com/ 

nimh_rdoc), the RDoC website, which 

also houses the RDoC matrix (https://

www.nimh.nih.gov/research-priorities/ 

rdoc/index.shtml), and several 

educational and training resources 

(including webinars) to educate the field 

and interface with scientists who may 

have questions about RDoC (https://

www.nimh.nih.gov/research-priorities/ 

rdoc/rdoc-educational-and-trainingresources.shtml). The evaluation 

approach will be conducted using 

surveys centered around current content 

(i.e., website, twitter, and webinars), as 

well as open ended surveys that will 

cover the scientific content of RDoC. 

The information collected will be used 

by NIMH staff to determine success of 

the RDoC initiative, develop future 

directions and endeavors, and to help 

guide programmatic priorities for RDoC 

and the Institute. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

490. 

ESTIMATED ANNUALIZED BURDEN HOURS

Instrument type Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Workshops ....................................................................................................... 50 1 8 400 

Interviews ......................................................................................................... 10 1 30/60 5

Surveys ............................................................................................................ 100 1 30/60 50 

Focus Groups .................................................................................................. 10 1 1 10 

Assessment Forms .......................................................................................... 100 1 15/60 25 

Total .......................................................................................................... 270 270 ........................ 490 


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