42868 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 

Dated: July 30, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–16705 Filed 8–4–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; 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 cooperative agreement 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the cooperative agreement applications, 

the disclosure of which would 


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Page 8 - Genentech, Inc. 

• Be accompanied by the authorized labeling, if the promotional materials are not 

subject to Section 502(n) of the Act. 

• Be.submitted to FDA accompanied by Fortn FDA:2253 at the time of initial 

dissemination or fast use. 

lfthe Agency notifies Genentech that any descriptive printed matter, advertising or 

promotional materials do not meet the terms set forth in conditions Q-S of this EUA; 

Genentech must cease distribution of such descriptive printed matter, advertising,-0r 

promotional materials in accordance with the Agency's notificati-On. Furthermore, as part 

of ifs notification, the Agency may also require Genentecht-0 issue rorrective 

communication(s ). 

R No descriptive printed matter, advertising, or promotional materials relating to the use of 

Actemra underthis authorization may represent or suggest that Actemra is safe or effective 

when used for :the treatment of COVID-19 in hospitalized adults and pediatric patients (2 

years of age and older) who are receiving systemic c-0rticosteroids and require 

supplemental oxygen,non-invasiveorinvasivemechamcal ventilation, or ECMO. 

S. Ail descriptive printed matter, advertising, and promotional material, relating to the use of 

Actemra under this authorization clearly and ronspicuously shall state that: 

• Actemra.has not been approved, but has been authorized for emergency use by 

FDA under an EU A, to treat COVID-19 in hospitalized adults and pediatric 

patients (2 years of age and older) who are receiving systemic corticosteroids 

and require supplemental oxygen,non-invasive or invasive mechanical 

ventilation, or ECMO; and 

•• Theemergencyuse of Actemrais only anthorizedforthe durationofthe 

declaration that circumstances existjustifying the authorization of the 

emergency use of drugs and biological products during the COVID-19 

pandemic under Section 564(b X 1) of the Act, 2 lU.S.C. § 36dbbb-3(b Xl ), 

unless the declaration is terminated or authorization revoked sooner; 

IV. Duration ofAuthorb.ation 

This EU A will be effective until the declaration that circumstances exist justifying the 

authorization of the emergency use of drugs and biological products during the COVID-19 

pandemic is terminated under Section 564(b )(2) of the Act or the EUA is revoked under Section 

564(g) ofthe Act. 

Sincerely, 

--JS!--

RADM Denise M. Hinton 

Chief Scientist 

Food_ ancl Drug Administration 
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 42869 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Advancing Translational Sciences Special 

Emphasis Panel; CTSA Review. 

Date: September 9, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

1037, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Victor Henriquez, Ph.D., 

Scientific Review Officer, National Center for 

Advancing Translational Sciences, National 

Institutes of Health, 6701 Democracy 

Boulevard, Room 1037, Bethesda, MD 20817, 

301–435–0813, henriquv@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: July 30, 2021. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–16668 Filed 8–4–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Draft NTP Developmental and 

Reproductive Toxicity Technical 

Reports on 2-Hydroxy-4- 

methoxybenzophenone and 2- 

Ethylhexyl p-Methoxycinnamate; 

Availability of Documents; Request for 

Comments; Notice of Peer-Review 

Meeting 

AGENCY: National Institutes of Health, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Division of the National 

Toxicology Program (DNTP) announces 

the availability of the Draft NTP 

Developmental and Reproductive 

Toxicity Technical Reports on 2- 

hydroxy-4-methoxybenzophenone and 

2-ethylhexyl p-methoxycinnamate 

scheduled for peer review. The peerreview meeting will be held remotely 

and will be available to the public for 

veiwing. Oral and written comments 

will be accepted; registration is required 

to access the webcast and to present oral 

comments. 

DATES: Meeting: October 14, 2021, 10 

a.m. Eastern Daylight Time (EDT) to 

adjournment. The meeting may end 

earlier or later than 5:00 p.m. EDT. 

Document Availability: The two draft 

NTP reports will be available by August 

16, 2021 at https://ntp.niehs.nih.gov/go/ 

36051. 

Written Public Comment 

Submissions: Deadline is September 30, 

2021. 

Registration for Oral Comments: 

Deadline is October 7, 2021. 

Registration to View the Webcast: 

Deadline is October 14, 2021. 

ADDRESSES: Meeting web page: The draft 

reports, preliminary agenda, 

registration, and other meeting materials 

will be available at https://

ntp.niehs.nih.gov/go/36051. Webcast: 

The URL for viewing the peer-review 

meeting will be provided to registrants. 

FOR FURTHER INFORMATION CONTACT: 

Email NTP-Meetings@icf.com. Dr. 

Sheena Scruggs, NIEHS/DNTP, is the 

Designated Federal Official. Phone: 

(984) 287–3355. Email: sheena.scruggs@

nih.gov. 

SUPPLEMENTARY INFORMATION: 

Meeting Attendance Registration: The 

meeting is available for viewing by the 

public with time set aside for oral 

public comment. Registration to view 

the webcast is by October 14, 2021, at 

https://ntp.niehs.nih.gov/go/36051. The 

URL for the webcast will be provided in 

the email confirming registration. 

Individuals with disabilities who need 

accommodation to view the webcast 

should contact Canden Byrd by phone: 

(919) 293–1660 or email: NTPMeetings@icf.com. TTY users should 

contact the Federal TTY Relay Service 

at (800) 877–8339. Requests should be 

made at least five business days in 

advance of the event. 

Request for Comments: DNTP invites 

written and oral public comments on 

the draft reports that address scientific 

or technical issues. Guidelines for 

public comments are available at 

https://ntp.niehs.nih.gov/ntp/about_

ntp/guidelines_public_comments_

508.pdf. 

The deadline for submission of 

written comments is September 30, 

2021, to enable review by the peerreview panel and DNTP staff prior to the 

meeting. Written public comments 

should be submitted through the 

meeting website at https://

ntp.niehs.nih.gov/go/36051. Persons 

submitting written comments should 

include name, affiliation, mailing 

address, phone, email, and sponsoring 

organization (if any). Written comments 

received in response to this notice will 

be posted on the NTP website and the 

submitter will be identified by name, 

affiliation, and sponsoring organization 

(if any). Comments that address 

scientific/technical issues will be 

forwarded to the peer-review panel and 

DNTP staff prior to the meeting. 

Oral public comment at this meeting 

is welcome, with time set aside for the 

presentation of oral comments on the 

draft reports. The agenda will allow for 

two oral public comment periods—one 

comment period per report (up to 6 

commenters, up to 5 minutes per 

speaker). Persons wishing to make an 

oral comment are required to register 

online at https://ntp.niehs.nih.gov/go/ 

36051 by October 7, 2021. Registration 

is on a first-come, first served basis. 

Each organization is allowed one time 

slot per report. The access number for 

the teleconference line will be provided 

to registrants by email prior to the 

meeting. Commenters will be notified 

approximately one week before the 

peer-review meeting about the actual 

time allotted per speaker. 

If possible, oral public commenters 

should send a copy of their slides and/ 

or statement or talking points to Canden 

Byrd by email: NTP-Meetings@icf.com 

by October 7, 2021. Written statements 

can supplement and may expand the 

oral presentation. 

Meeting Materials: The draft NTP 

reports and preliminary agenda will be 

available on the NTP website at https:// 

ntp.niehs.nih.gov/go/36051 prior to the 

meeting. NTP expects that the draft 

reports should be available on the 

website by August 16, 2021. Additional 

information will be posted when 

available or may be requested in 

hardcopy from Canden Byrd by phone: 

(919) 293–1660 or email: NTPMeetings@icf.com. Individuals are 

encouraged to access the meeting web 

page to stay abreast of the most current 

information regarding the meeting. 

Following the meeting, a report of the 

peer review will be prepared and made 

available on the NTP website. 

Background Information on NTP PeerReview Panels: NTP panels are 

technical, scientific advisory bodies 

established on an ‘‘as needed’’ basis to 

provide independent scientific peer 

review and advise NTP on agents of 

public health concern, new/revised 

toxicological test methods, or other 

issues. These panels help ensure 

transparent, unbiased, and scientifically 

rigorous input to the program for its use 

in making credible decisions about 

human hazard, setting research and 

testing priorities, and providing 

information to regulatory agencies about 

alternative methods for toxicity 

screening. DNTP welcomes nominations 

of scientific experts for upcoming 

panels. Scientists interested in serving 

on an NTP panel should provide their 

name and best form of contact to 


khammond on DSKJM1Z7X2PROD with NOTICES