Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 4897 

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 ‘‘Principles of 

Premarket Pathways for Combination 

Products.’’ 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 3 and in the 

guidance ‘‘How to Prepare a Pre-Request 

for Designation (Pre-RFD)’’ have been 

approved under OMB control number 

0910–0523. The collections of 

information for applications for FDA 

approval to market a new drug (certain 

provisions of 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 section 

351(k) of the Public Health Service Act 

(42 U.S.C. 262) have been approved 

under 0910–0719. The collections of 

information in 21 CFR part 807, subpart 

E, have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in 21 CFR part 860, 

subparts A through C, have been 

approved under OMB control number 

0910–0138; the collections of 

information in the guidance document 

‘‘Requests for Feedback and Meetings 

for Medical Device Submissions: The QSubmission Program’’ have been 

approved under OMB control number 

0910–0756; and the collections of 

information in 21 CFR part 860, subpart 

D, for De Novo classifications have been 

approved under OMB control number 

0910–0844. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/combination-products/ 

guidance-regulatory-information/ 

combination-products-guidancedocuments, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: January 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01925 Filed 1–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0008] 

Advisory Committee; Vaccines and 

Related Biological Products Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the Vaccines 

and Related Biological Products 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Vaccines and 

Related Biological Products Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

December 31, 2023, expiration date. 

DATES: Authority for the Vaccines and 

Related Biological Products Advisory 

Committee will expire on December 31, 

2023, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Prabhakara Atreya, Division of 

Scientific Advisors and Consultants, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 6306, Silver Spring, 

MD 20993–0002, 240–402–8006, 

Prabhakara.Atreya@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Vaccines and Related 

Biological Products Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective vaccines and related biological 

products for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

which are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, and, as required, any 

other products for which FDA has 

regulatory responsibility. The 

Committee also considers the quality 

and relevance of FDA’s research 

program, which provides scientific 

support for the regulation of these 

products and makes appropriate 

recommendations to the Commissioner. 

The Committee shall consist of a core 

of 15 voting members, including the 

Chairperson (the Chair). Members and 

the Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of immunology, molecular biology, 

rDNA, virology, bacteriology, 

epidemiology or biostatistics, vaccine 

policy, vaccine safety science, federal 

immunization activities, vaccine 

development including translational 

and clinical evaluation programs, 

allergy, preventive medicine, infectious 

diseases, pediatrics, microbiology, and 

biochemistry. Members will be invited 

to serve for overlapping terms of up to 

4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. Ex 

Officio voting members, one each from 

the Department of Health and Human 

Services, the Centers for Disease Control 

and Prevention, and the National 

Institutes of Health may be included. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include one non-voting member who is 

identified with industry interests. There 

may also be an alternate industry 

representative. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) Expertise is required that is not 

available among current voting standing 


khammond on DSKJM1Z7X2PROD with NOTICES
4898 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members) or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, a non-voting representative of 

consumer interests and a non-voting 

representative of industry interests will 

be included in addition to the voting 

members. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

vaccines-and-related-biologicalproducts-advisory-committee/chartervaccines-and-related-biologicalproducts-advisory-committee or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: January 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01858 Filed 1–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Childhood Vaccines 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Commission on Childhood Vaccines 

(ACCV) will hold public meetings for 

the 2022 calendar year (CY). 

Information about the ACCV, agendas, 

and materials for these meetings can be 

found on the ACCV website at https:// 

www.hrsa.gov/advisory-committees/ 

vaccines/index.html. 

DATES: ACCV meetings will be held on: 

• March 3, 2022, 10:00 a.m. Eastern 

Time (ET)–4:00 p.m. ET; 

• June 2, 2022, 10:00 a.m. ET–4:00 

p.m. ET; 

• September 1, 2022, 10:00 a.m. ET– 

4:00 p.m. ET; and 

• December 1, 2022, 10:00 a.m. ET– 

4:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson or virtually. For updates on how 

the meeting will be held, visit the ACCV 

website 30 business days before the 

meeting date, where instructions for 

joining meetings either in-person or 

remotely will be posted. In-person 

ACCV meetings will be held at 5600 

Fishers Lane, Rockville, Maryland 

20857. For meeting information 

updates, go to the ACCV website 

meeting page at https://www.hrsa.gov/ 

advisory-committees/vaccines/ 

meetings.html. 

FOR FURTHER INFORMATION CONTACT: 

Annie Herzog, Division of Injury 

Compensation Programs, HRSA, 5600 

Fishers Lane, 08N186B, Rockville, 

Maryland 20857; 301–443–6634; or 

ACCV@HRSA.gov. 

SUPPLEMENTARY INFORMATION: The ACCV 

provides advice and recommendations 

to the Secretary of HHS on policy, 

program development, and other issues 

related to the implementation of the 

National Vaccine Injury Compensation 

Program and concerning other matters 

as described under section 2119 of the 

Public Health Service Act (42 U.S.C. 

300aa–19). 

Since priorities dictate meeting times, 

be advised that times and agenda items 

are subject to change. Refer to the ACCV 

website listed above for any meeting 

updates that may occur. For CY 2022 

meetings, agenda items may include, 

but are not limited to: Updates from the 

Division of Injury Compensation 

Programs, Department of Justice, Office 

of Infectious Disease and HIV/AIDS 

Policy (HHS), Immunization Safety 

Office (Centers for Disease Control and 

Prevention), National Institute of 

Allergy and Infectious Diseases 

(National Institutes of Health) and 

Center for Biologics, Evaluation and 

Research (Food and Drug 

Administration). Refer to the ACCV 

website listed above for all current and 

updated information concerning the CY 

2022 ACCV meetings, including draft 

agendas and meeting materials posted 5 

calendar days before the meeting(s). 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting(s). Oral comments will be 

honored in the requested order and may 

be limited as time allows. Requests to 

submit a written statement or make oral 

comments to ACCV should be sent to 

Annie Herzog using the contact 

information above at least 5 business 

days before the meeting date(s). 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Annie 

Herzog using the contact information 

listed above at least 10 business days 

before the meeting(s) they wish to 

attend. If in-person meetings occur, they 

will be held in a federal government 

building and attendees must go through 

a security check to enter the building. 

Non-U.S. Citizen attendees must notify 

HRSA of their planned attendance at 

least 20 business days before the 

meeting to facilitate their entry into the 

building. All attendees are required to 

present government-issued 

identification before entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–01848 Filed 1–28–22; 8:45 am] 

BILLING CODE 4165–15–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: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Biobehavioral Mechanisms of 

Emotion, Stress and Health Study Section. 

Date: February 24–25, 2022. 

Time: 10:00 a.m. to 8:00 p.m. 


khammond on DSKJM1Z7X2PROD with NOTICES