60 day FRN

jspears on DSK121TN23PROD with NOTICES1

Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
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:
[email protected].
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.

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.

Public Participation

BILLING CODE 4163–18–P

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]

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

VerDate Sep<11>2014

18:27 Mar 17, 2022

Jkt 256001

PO 00000

Frm 00076

Fmt 4703

Sfmt 4703

15433

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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
SUMMARY:

E:\FR\FM\18MRN1.SGM

18MRN1

15434

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

H21–8, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].
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).

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.

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

jspears on DSK121TN23PROD with NOTICES1

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

Type of respondent

Form name

General public, individuals or households.

Screening instrument .......................

20,000

1

15/60

5,000

Consent form ....................................
Introductory Surveys ........................

10,000
10,000

1
1

20/60
30/60

3,330
5,000

VerDate Sep<11>2014

18:27 Mar 17, 2022

Jkt 256001

PO 00000

Frm 00077

Fmt 4703

Sfmt 4703

E:\FR\FM\18MRN1.SGM

18MRN1

15435

Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent

Stakeholders of local entities affected by TBDs.
Total ...........................................

10,000
10,000
10,000
1,000

12
1
60
1

15/60
30/60
10/60
30/60

30,000
5,000
50,000
500

...........................................................

........................

........................

........................

98,830

[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
Food and Drug Administration,

HHS.
ACTION:

Notice; request for comments.

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,

jspears on DSK121TN23PROD with NOTICES1

SUMMARY:

VerDate Sep<11>2014

18:27 Mar 17, 2022

Total
burden
hours

Monthly surveys ...............................
Final surveys ....................................
Daily surveys ....................................
Stakeholder Survey ..........................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

AGENCY:

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Form name

Jkt 256001

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

PO 00000

Frm 00078

Fmt 4703

Sfmt 4703

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

E:\FR\FM\18MRN1.SGM

18MRN1