Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 15433 

for Occupational Safety and Health, 

1090 Tusculum Avenue, MS C–34, 

Cincinnati, Ohio 45226. 

Instructions: All submissions received 

must include the Agency name and 

Docket Number. Written public 

comments received by April 13, 2022, 

will be provided to the BSC prior to the 

meeting. Docket number CDC–2022– 

0037; and NIOSH–278 will close April 

13, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Emily J.K. Novicki, M.A., M.P.H., 

Executive Secretary, BSC, NIOSH, CDC, 

1600 Clifton Avenue, MS V24–4, 

Atlanta, Georgia 30329–4027, 

Telephone: (404) 498–2581, Email: 

enovicki@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The Secretary, the Assistant 

Secretary for Health, and by delegation 

the Director, Centers for Disease Control 

and Prevention, are authorized under 

Sections 301 and 308 of the Public 

Health Service Act to conduct directly 

or by grants or contracts, research, 

experiments, and demonstrations 

relating to occupational safety and 

health and to mine health. The Board of 

Scientific Counselors provides guidance 

to the Director, National Institute for 

Occupational Safety and Health on 

research and prevention programs. 

Specifically, the Board provides 

guidance on the Institute’s research 

activities related to developing and 

evaluating hypotheses, systematically 

documenting findings and 

disseminating results. The Board 

evaluates the degree to which the 

activities of the National Institute for 

Occupational Safety and Health: (1) 

Conform to appropriate scientific 

standards, (2) address current, relevant 

needs, and (3) produce intended results. 

Matters to be Considered: The agenda 

for the meeting addresses the evolving 

national landscape for respiratory 

protection and occupational robotics 

research. Agenda items are subject to 

change as priorities dictate. 

An agenda is also posted on the 

NIOSH website (http://www.cdc.gov/ 

niosh/bsc/). 

Meeting Information: It is open to the 

public, limited only by web conference 

lines (500 web conference lines are 

available). If you wish to attend, please 

register at the NIOSH website http://

www.cdc.gov/niosh/bsc/ or call (404– 

498–2581) no later than April 13, 2022. 

Public Participation 

Comments received are part of the 

public record and are subject to public 

disclosure. Do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

CDC does not accept comment by email. 

Oral Public Comment: The public is 

welcome to participate during the 

public comment period, from 1:00 p.m. 

to 1:15 p.m., EDT, April 20, 2022. Please 

note that the public comment period 

ends at the time indicated above. Each 

commenter will be provided up to five 

minutes for comment. A limited number 

of time slots are available and will be 

assigned on a first come-first served 

basis. Members of the public who wish 

to address the BSC NIOSH are requested 

to contact the Executive Secretary for 

scheduling purposes (see FOR FUTHER

INFORMATION above). 

Written Public Comment: Written 

comments will also be accepted from 

those unable to attend the public 

session per the instructions provided in 

the addresses section above. Written 

comments received in advance of the 

meeting will be included in the official 

record of the meeting. Written 

comments received by April 13, 2022, 

will be provided to the BSC prior to the 

meeting. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–05798 Filed 3–17–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–22–1150; Docket No. CDC–2022– 

0035] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled Generic Clearance for Lyme and 

other Tickborne Diseases (TBD) 

Knowledge, Attitudes, and Practices 

(KAP) Surveys. This data collection 

involves the administration of a set of 

surveys designed to understand KAPs 

related to prevention of Lyme and other 

TBDs and to inform implementation of 

future TBD prevention interventions. 

DATES: CDC must receive written 

comments on or before May 17, 2022. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2022– 

0035 by either of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS 


jspears on DSK121TN23PROD with NOTICES1
15434 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 

H21–8, Atlanta, Georgia 30329; phone: 

404–639–7570; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

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 

Generic Clearance for Lyme and other 

Tickborne Diseases (TBD) Knowledge, 

Attitudes, and Practices (KAP) Surveys 

(OMB Control No. 0920–1150, Exp. 9/ 

30/2022)—Revision—National Center 

for Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC) Division of VectorBorne Diseases (DVBD) and other 

programs working on tickborne diseases 

(TBDs) are requesting a Revision to a 

previously approved generic clearance 

to conduct TBD prevention studies to 

include knowledge, attitudes, and 

practices (KAP) surveys TBDs among 

residents and businesses offering pest 

control services in Lyme disease 

endemic areas of the United States. The 

data collection for which approval is 

sought will allow DVBD to use survey 

results to inform implementation of 

future TBD prevention interventions. 

The Revision involves a broadening of 

the secondary target population from 

owners and employees of pest control 

companies to stakeholders of local 

entities affected by TBDs (e.g., leaders in 

local public health or local government; 

owners or employees of pest control 

companies, landscaping companies, or 

other at-risk occupations; nongovernmental organizations serving atrisk populations; and/or clinicians 

serving at-risk populations). 

TBDs are a substantial and growing 

public health problem in the United 

States. From 2004–2016, over 490,000 

cases of TBDs were reported to CDC, 

including cases of anaplasmosis, 

babesiosis, ehrlichiosis, Lyme disease, 

Rocky Mountain spotted fever, and 

tularemia. Lyme disease accounted for 

82% of all TBDs, with over 400,000 

cases reported during this time period. 

Recent studies estimate nearly 500,000 

cases of Lyme disease are diagnosed 

annually in the United States. In 

addition, several novel tickborne 

pathogens have recently been found to 

cause human disease in the United 

States. Factors driving the emergence of 

TBDs are not well defined and current 

prevention methods have been 

insufficient to curb the increase in 

cases. Data is lacking on how often 

certain prevention measures are used by 

individuals at risk as well as what the 

barriers to using certain prevention 

measure are. 

The primary target population for 

these data collections are individuals 

and their household members who are 

at risk for TBDs associated with 

I.scapularis ticks and who may be 

exposed to these ticks residentially, 

recreationally, and/or occupationally. 

The secondary target population 

includes stakeholders of local entities 

affected by TBDs (e.g., leaders in local 

public health or local government; 

owners or employees of pest control 

companies, landscaping companies, or 

other at-risk occupations; nongovernmental organizations serving atrisk populations; and/or clinicians 

serving at-risk populations) in areas 

where I. scapularis ticks transmit 

diseases to humans. Specifically, these 

target populations include those 

residing or working in the 15 highest 

incidence states for Lyme disease (CT, 

DE, ME, MD, MA, MN, NH, NJ, NY, PA, 

RI, VT, VA, WI and WV). We anticipate 

conducting one to two surveys per year, 

for a maximum of six surveys conducted 

over a three-year period. Depending on 

the survey, we aim to enroll 500–10,000 

participants per study. It is expected 

that we will need to target recruitment 

to about twice as many people as we 

intend to enroll. Surveys may be 

conducted daily, weekly, monthly, or 

bi-monthly per participant for a defined 

period (whether by phone or web 

survey), depending on the survey or 

study. The surveys will range in 

duration from approximately 5–30 

minutes. Each participant may be 

surveyed 1–64 times in one year; this 

variance is due to differences in the type 

of information collected for a given 

survey. Specific burden estimates for 

each study and each information 

collection instrument will be provided 

with each individual project submission 

for OMB review. 

Insights gained from KAP surveys will 

aid in prioritizing which prevention 

methods should be evaluated in future 

randomized, controlled trials and 

ultimately help target promotion of 

proven prevention methods that could 

yield substantial reductions in TBD 

incidence. CDC requests OMB approval 

for an estimated 98,830 annual burden 

hours. There is no cost to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

General public, individuals or households.Screening instrument ....................... 20,000 1 15/60 5,000 

Consent form .................................... 10,000 1 20/60 3,330 

Introductory Surveys ........................ 10,000 1 30/60 5,000 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 15435 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Monthly surveys ............................... 10,000 12 15/60 30,000 

Final surveys .................................... 10,000 1 30/60 5,000 

Daily surveys .................................... 10,000 60 10/60 50,000 

Stakeholders of local entities affected by TBDs.Stakeholder Survey .......................... 1,000 1 30/60 500 

Total ........................................... ........................................................... ........................ ........................ ........................ 98,830 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–05753 Filed 3–17–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0297] 

Draft Pharmaceutical Quality/ 

Chemistry Manufacturing and Controls 

Data Exchange; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting comment on the draft 

Pharmaceutical Quality/Chemistry 

Manufacturing and Controls (PQ/CMC) 

Data Exchange for the electronic 

submission of PQ/CMC data. This 

document provides draft design of 

Health Level 7 (HL7) Fast Health 

Interoperability Resources (FHIR) 

profiles that contain the data elements 

and terminologies associated with PQ/ 

CMC subject areas and scoped to some 

of what is currently submitted in 

Module 3 of the electronic Common 

Technical Document (eCTD) 

submission. It is not intended to be 

comprehensive in covering all eCTD 

product quality information, only those 

concepts that were considered amenable 

to structuring and would bring value to 

the quality review process. The Agency 

is seeking comment on the mapping of 

the PQ/CMC data elements to the 

various FHIR Resources. This document 

should not be viewed as guidance, 

technical specification, or an 

implementation guide, as it is meant 

solely for comment. The FHIR mapping 

presented in this document is bound to 

the HL7 FHIR R5 draft release. As such, 

it is likely that some parts of the 

mapping presented in this document 

may change based on comments during 

the HL7 balloting and reconciliation 

process. However, since HL7 balloting 

has variable and extensive timelines, the 

Agency determined that it would be 

prudent to provide an early opportunity 

for comment that will inform final 

development of the exchange standard. 

DATES: Submit either electronic or 

written comments by May 17, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 17, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 17, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2022–N–0297 for ‘‘Draft Pharmaceutical 

Quality/Chemistry Manufacturing and 

Controls (PQ/CMC) Data Exchange for 

the electronic submission of PQ/CMC 

data; Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 


jspears on DSK121TN23PROD with NOTICES1