Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 4895 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Fire Fighter Fatality Investigation and 

Prevention Program (FFFIPP) Survey— 

New—National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The FFFIPP conducts independent 

investigations of fire fighter (FF) line-ofduty deaths and recommends ways to 

prevent deaths and injuries. In 2003, an 

evaluation was conducted to determine 

the extent to which recommendations 

from NIOSH investigations of FF 

fatalities are being implemented by fire 

departments (FDs). Since then, there 

have been changes to the FFFIPP 

recommendations and methods of 

disseminating FFFIPP reports. For 

example, there have been changes to: (1) 

The details and types of 

recommendations for preventing FF 

fatalities, and (2) the method to 

disseminate the FFFIPP reports to FDs 

(driven in large part by cost). 

Dissemination methods have evolved 

from hardcopy mailings to FDs to 

internet-based, with notifications of new 

FFFIPP reports by the fire service media 

and if FDs sign-up at the NIOSH website 

for notifications of new reports. 

Understanding how or if NIOSH 

recommendations are used by various 

types of FDs will allow a better 

understanding of barriers to the use of 

proven prevention recommendations 

and help identify approaches to 

improve the delivery of services to FDs. 

Additionally, we will gain insight into 

whether changes to the communication 

and dissemination have impacted the 

reach of these recommendations. 

Knowing if different types of FDs are 

aware of and willing to access FFFIPP 

reports and recommendations in nonprint formats is critical, as these 

recommendations cannot have the 

intended impact of saving FF lives if 

large numbers of FDs do not know 

where to find NIOSH reports or have the 

resources to access them. 

This data collection will assess FD 

implementation of the NIOSH FFFIPP 

recommendations and identify barriers 

to implementation of recommendations. 

Results will provide an understanding 

of current FD operational procedures, 

insight into motor vehicle-related 

activities and related policies and 

identify whether FFFIPP 

recommendations are being utilized by 

FDs. Findings will inform strategies for 

communication of future 

recommendations and identify areas for 

potential intervention projects in order 

to improve the delivery of services and 

help ensure an effective and efficient 

stakeholder experience with the FFFIPP. 

The estimate for burden hours is 

based on a pilot test of the survey 

instrument by eight FD personnel. In the 

pilot test, the average time to complete 

the survey including time for reviewing 

instructions, gathering needed 

information, and completing the survey 

was 10–25 minutes. For the purposes of 

estimating burden hours, the upper 

limit of this range is used. There are 

screening questions at the beginning of 

the survey so all respondents may not 

actually participate. 

The respondent universe is based on: 

(1) 4,500 FDs, (2) eight strata (region, 

department type), and (3) position (FF, 

chief, company officer). An estimated 

13,500 respondents are anticipated to 

participate in the survey. The annual 

respondent burden is estimated to be 

4,050 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Fire Fighters ...................................... Survey .............................................. 4,500 1 18/60 1,350 

Fire Chiefs ......................................... Survey .............................................. 4,500 1 18/60 1,350 

Company Officers ............................. Survey .............................................. 4,500 1 18/60 1,350 

Total ........................................... ........................................................... ........................ ........................ ........................ 4,050 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–01825 Filed 1–28–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–0078] 

Principles of Premarket Pathways for 

Combination Products; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry and FDA staff 

entitled ‘‘Principles of Premarket 

Pathways for Combination Products.’’ 

This guidance presents FDA’s current 

thinking on principles for premarket 

review of combination products. This 

guidance includes general, high-level 

information regarding what combination 

products are, coordination within FDA 

and interaction between FDA and 

sponsors regarding combination product 

regulation, and how combination 

products are reviewed by FDA before 


khammond on DSKJM1Z7X2PROD with NOTICES
4896 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 

they are marketed. The guidance also 

includes recommendations on how to 

determine which type of premarket 

submissions may be appropriate for 

combination products. FDA is 

publishing this guidance as part of its 

efforts to implement the 21st Century 

Cures Act (Cures Act) and in keeping 

with the Agency’s long-standing 

commitment to transparency, efficiency, 

and regulatory consistency to facilitate 

development of safe and effective 

combination products. This guidance 

finalizes the draft guidance of the same 

title that published on February 6, 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 31, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–0078 for ‘‘Principles of 

Premarket Pathways for Combination 

Products.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Office of 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002, 301–796–8930, 

john.weiner@fda.hhs.gov or 

combination@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Principles of Premarket 

Pathways for Combination Products.’’ 

This guidance presents FDA’s current 

thinking on principles for premarket 

review of combination products. This 

guidance includes general, high-level 

information regarding what combination 

products are, coordination within FDA 

and interaction between FDA and 

sponsors regarding combination product 

regulation, and how combination 

products are reviewed by FDA before 

they are marketed. The guidance also 

includes recommendations on how to 

determine which type of premarket 

submissions may be appropriate for 

combination products, as well as 

illustrative examples. 

Section 3038 of the Cures Act (Pub. L. 

114–255), enacted in December 2016, 

substantially amended section 503(g) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 353(g)), the 

principal section of the FD&C Act 

expressly addressing combination 

products. General themes of these 

amendments include enhancing clarity, 

predictability, efficiency, and 

consistency of premarket regulatory 

expectations for combination products, 

including by ensuring that Agency 

components and staff coordinate 

appropriately on premarket review of 

these products, and that Agency 

thinking is aligned in conducting these 

reviews. This guidance is part of FDA’s 

efforts to implement section 3038 of the 

Cures Act. 

In the Federal Register of February 6, 

2019 (84 FR 2236), FDA announced the 

availability of the draft guidance of the 

same title. FDA received comments and 

considered those comments as the 

guidance was finalized. The final 

guidance clarifies the guidance 

including its applicability across 

combination product types and 

additional detail regarding processes for 

interacting with the Agency. 


khammond on DSKJM1Z7X2PROD with NOTICES
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