Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35307 

trials conducted exclusively in patients 

with CNS metastases. 

CNS metastases are associated with 

significant morbidity and mortality and 

development of therapeutic products for 

patients with CNS metastases is needed. 

FDA has participated in efforts to 

facilitate drug development for patients 

with CNS metastases, including a March 

2019 ‘‘Workshop on Product 

Development for CNS Metastases.’’ 

Stakeholders at this meeting stated there 

is a need for further FDA guidance on 

specific topics, including identifying 

optimal study endpoints. Study design 

challenges for CNS metastases include 

uncertainty regarding optimal 

endpoints, lack of standardized 

response assessments, understanding 

how CNS metastases are evaluated in 

the context of the entire burden of 

metastatic disease to characterize a 

drug’s potential benefit (e.g., timing of 

CNS radiographic assessments relative 

to other sites of metastases), and 

interpreting radiographic response in 

the setting of recent radiation therapy or 

surgery. This guidance is intended to 

provide recommendations on these 

study design challenges. 

In the Federal Register of August 27, 

2020 (85 FR 53007), FDA announced the 

availability of the draft guidance 

‘‘Evaluating Cancer Drugs in Patients 

with Central Nervous System 

Metastases’’ dated August 2020. FDA 

received several comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. A summary of changes 

includes: Clarification on the number of 

stratification factors the protocol should 

specify in order to minimize bias, 

confirmation of the version of Response 

Evaluation Criteria in Solid Tumours 

(RECIST) that should be referred to 

when evaluating CNS disease, 

clarification that both CNS and 

systematic duration of response should 

be captured and the addition of a 6- 

month timepoint, and the addition of 

progression-free survival in patients 

with brain metastasis as another 

measurement to be reported when CNS 

is a common metastatic site. In addition, 

editorial changes were made to improve 

clarity. The guidance announced in this 

notice finalizes the draft guidance dated 

August 27, 2020. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Evaluating Cancer 

Drugs in Patients with Central Nervous 

System Metastases.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 601 have 

been approved under 0910–0338; and 

the collections of information in 21 CFR 

201.56 and 201.57 have been approved 

under OMB control number 0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances or https://

www.regulations.gov. 

Dated: June 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14194 Filed 7–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that RYPLAZIM 

(plasminogen, human-tvmh), 

manufactured by Prometic 

Bioproduction, Inc., meets the criteria 

for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that RYPLAZIM (plasminogen, humantvmh), manufactured by Prometic 

Bioproduction, Inc., meets the criteria 

for a priority review voucher. 

RYPLAZIM (plasminogen, human-tvmh) 

is indicated for the treatment of patients 

with plasminogen deficiency type 1 

(hypoplasminogenemia). 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/industry/ 

developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For 

further information about RYPLAZIM 

(plasminogen, human-tvmh), go to the 

Center for Biologics Evaluation and 

Research Cellular and Gene Therapy 

Products website at https://

www.fda.gov/vaccines-blood-biologics/ 

cellular-gene-therapy-products/ 

approved-cellular-and-gene-therapyproducts. 

Dated: June 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14191 Filed 7–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 


lotter on DSK11XQN23PROD with NOTICES1
35308 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; HIV Vaccine Research and 

Design (HIVRAD) Program (P01 Clinical Trial 

Not Allowed). 

Date: July 29, 2021. 

Time: 9:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G11A, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: J. Bruce Sundstrom, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G11A, 

Rockville, MD 20852, 240–669–5045, 

sundstromj@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: June 28, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–14173 Filed 7–1–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Toxicology Program Board of 

Scientific Counselors; Announcement 

of Meeting; Request for Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the National Toxicology 

Program (NTP) Board of Scientific 

Counselors (BSC). The BSC, a federally 

chartered, external advisory group 

composed of scientists from the public 

and private sectors, will review and 

provide advice on programmatic 

activities. This meeting is a virtual 

meeting and is open to the public. 

Written comments will be accepted and 

registration is required to present oral 

comments. Information about the 

meeting and registration are available at 

https://ntp.niehs.nih.gov/go/165. 

DATES: 

Meeting: Scheduled for August 4, 

2021, 12:30 p.m.–5:00 p.m. Eastern 

Daylight Time (EDT). 

Written Public Comment 

Submissions: Deadline is July 28, 2021. 

Registration for Oral Comments: 

Deadline is July 28, 2021. 

ADDRESSES: 

Meeting web page: The preliminary 

agenda, registration, and other meeting 

materials are available at https://

ntp.niehs.nih.gov/go/165. 

Virtual Meeting: The URL for viewing 

the virtual meeting will be provided on 

the meeting web page the day before the 

meeting. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Sheena Scruggs, Designated Federal 

Official for the BSC, Office of Policy, 

Review, and Outreach, Division of NTP, 

NIEHS, P.O. Box 12233, K2–03, 

Research Triangle Park, NC 27709. 

Phone: 984–287–3355, Fax: 301–451– 

5759, Email: sheena.scruggs@nih.gov. 

Hand Deliver/Courier address: 530 

Davis Drive, Room K2126, Morrisville, 

NC 27560. 

SUPPLEMENTARY INFORMATION: The BSC 

will provide input to the NTP on 

programmatic activities and issues. The 

preliminary agenda topics include 

presentations from two of the Division 

of the National Toxicology Program 

(DNTP)’s research program areas. The 

preliminary agenda, roster of BSC 

members, background materials, public 

comments, and any additional 

information, when available, will be 

posted on the BSC meeting web page 

(https://ntp.niehs.nih.gov/go/165) or 

may be requested in hardcopy from the 

Designated Federal Official for the BSC. 

Following the meeting, summary 

minutes will be prepared and made 

available on the BSC meeting web page. 

Meeting Attendance Registration: The 

meeting is open to the public with time 

scheduled for oral public comments. 

Registration is not required to view the 

virtual meeting; the URL for the virtual 

meeting is provided on the BSC meeting 

web page (https://ntp.niehs.nih.gov/go/ 

165) the day before the meeting. 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. 

Written Public Comments: NTP 

invites written public comments. 

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 July 28, 2021. 

Written public comments should be 

submitted through the meeting web 

page. 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 web page, and the submitter 

will be identified by name, affiliation, 

and sponsoring organization (if any). 

Oral Public Comment Registration: 

The agenda allows for two formal public 

comment periods—one comment period 

for each program area (up to 3 

commenters, up to 5 minutes per 

speaker, per topic). Persons wishing to 

make an oral comment are required to 

register online at https://

ntp.niehs.nih.gov/go/165 by July 28, 

2021. Oral comments will be received 

only during the formal comment periods 

indicated on the preliminary agenda. 

Oral comments will only be by 

teleconference line. The access number 

for the teleconference line will be 

provided to registrants by email prior to 

the meeting. Registration is on a firstcome, first-served basis. Each 

organization is allowed one time slot 

per topic. After the maximum number of 

speakers per comment period is 

exceeded, individuals registered to 

provide oral comment will be placed on 

a wait list and notified should an 

opening become available. Commenters 

will be notified approximately one week 

before the 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 NTPMeetings@icf.com by July 28, 2021. 

Meeting Materials: The preliminary 

meeting agenda is available on the 

meeting web page (https://

ntp.niehs.nih.gov/go/165) and will be 

updated one week before the meeting. 

Individuals are encouraged to access the 

meeting web page to stay abreast of the 

most current information regarding the 

meeting. 

Background Information on the BSC: 

The BSC is a technical advisory body 

comprised of scientists from the public 

and private sectors that provides 

primary scientific oversight to the NTP. 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

epidemiology, risk assessment, 

carcinogenesis, mutagenesis, cellular 


lotter on DSK11XQN23PROD with NOTICES1