11724 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

OMB control number 0910–0338; the 

collections of information in §§ 201.56 

and 201.57 for the content and format 

requirements for labeling of human 

prescription drug and biological 

products have been approved under 

OMB control number 0910–0572. 

In addition, the following collections 

of information in FDA’s guidances have 

been approved by OMB (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents): 

• Collections in FDA’s draft guidance 

for industry entitled ‘‘Formal Meetings 

Between the FDA and Sponsors and 

Applicants for PDUFA Products’’ have 

been approved under OMB control 

number 0910–0429. 

• Collections in FDA’s guidance for 

industry entitled ‘‘Special Protocol 

Assessment’’ have been approved under 

OMB control number 0910–0470. 

• Collections in FDA’s guidance for 

industry entitled ‘‘Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees’’ have been 

approved under OMB control number 

0910–0581. 

• Collections in FDA’s guidance for 

industry entitled ‘‘Oversight of Clinical 

Investigations—A Risk-Based Approach 

to Monitoring’’ have been approved 

under OMB control number 0910–0733. 

• Collections in FDA’s guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ have been approved under 

OMB control number 0910–0765. 

• Collections in FDA’s guidance for 

industry entitled ‘‘E6(R2) Good Clinical 

Practice: Integrated Addendum to ICH 

E6(R1)’’ have been approved under 

OMB control number 0910–0843. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: February 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04398 Filed 3–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Vaccines Federal 

Implementation Plan 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, Office of Infectious Disease and 

HIV/AIDS Policy. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services’ Office of Infectious 

Disease and HIV/AIDS Policy in the 

Office of the Assistant Secretary for 

Health announces that the draft 

Vaccines Federal Implementation Plan 

2021–2025 is available for public 

comment. The Vaccines Federal 

Implementation Plan is a companion 

document to the Vaccines National 

Strategic Plan 2021–2025 (VNSP), 

which was published in January 2021. 

The Vaccines Federal Implementation 

Plan is a compilation of federal agency 

immunization activities that collectively 

advance the goals of the VNSP. Its target 

audience is other federal agencies and 

external partners who work in the area 

of vaccination. The public will be 

interested in how the implementation 

plan documents federal agency efforts. It 

does not outline mandates or other 

COVID–19 response measures. 

DATES: The public comment period for 

the Vaccines Federal Implementation 

Plan starts on February 28, 2022 at 9 

a.m. ET and ends on March 29, 2022 at 

5 p.m. ET. All comments must be 

received by 5 p.m. ET on March 29, 

2022 to be considered. 

ADDRESSES: All comments must be 

submitted electronically to nvp.rfi@

hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

David Kim, MD, MA, Director, Division 

of Vaccines, Office of Infectious Disease 

and HIV/AIDS Policy, Office of the 

Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, Room L616, Switzer Building, 

330 C St. SW, Washington, DC 20024. 

Phone: 202–795–7697; Email: nvp.rfi@

hhs.gov. 

Dated: February 17, 2022. 

David Kim, 

Designated Federal Officer, Vaccines Federal 

Implementation Plan, Office of the Assistant 

Secretary for Health. 

[FR Doc. 2022–04327 Filed 3–1–22; 8:45 am] 

BILLING CODE 4150–44–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. 

DATES: 

Meeting: Scheduled for April 19, 

2022, 12:30 p.m.–2:00 p.m. Eastern 

Standard Time (EST). Ending times are 

approximate; meeting may end earlier or 

run later. 

Written Public Comment 

Submissions: Deadline is April 12, 2022. 

Registration for Oral Comments: 

Deadline is April 12, 2022. 

ADDRESSES:

Meeting Web Page: The preliminary 

agenda, registration, and other meeting 

materials will be available at https://

ntp.niehs.nih.gov/go/165 by March 14, 

2022. 

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. 

Mary Wolfe, 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– 

287–3209, Fax: 301–451–5759, Email: 

wolfe@niehs.nih.gov. Hand Deliver/ 

Courier address: 530 Davis Drive, Room 

K2130, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: The BSC 

will provide input to the NTP on 

programmatic activities and issues. The 

preliminary agenda topics include 

presentations on a contract concept: 

Bioinformatics Support for the NIEHS. 

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 


lotter on DSK11XQN23PROD with NOTICES1