60 day FRN

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63390

Federal Register / Vol. 86, No. 218 / Tuesday, November 16, 2021 / Notices

The Patient Safety Act also authorizes
the development of data standards,
known as the Common Formats, to
facilitate the aggregation and analysis of
non-identifiable patient safety data
collected by PSOs and reported to the
network of patient safety databases
(NPSD). (42 U.S.C. 299b–23(b)). The
Patient Safety Act and Patient Safety
Rule can be accessed at: http://
www.pso.ahrq.gov/legislation/.
AHRQ has issued Common Formats
for Event Reporting for three settings of
care—hospitals, nursing homes, and
community pharmacies. As part of the
agency’s efforts to improve diagnostic
safety and quality in healthcare, AHRQ
is in the process of developing Common
Formats for Event Reporting—
Diagnostic Safety (CFER–DS). The
CFER–DS is intended to help healthcare
providers identify and report missed
opportunities in the diagnostic process
in a standardized manner across
healthcare settings and specialties.
Widespread use of the CFER–DS will
make it possible to collect, aggregate,
and analyze diagnostic safety-related
information from healthcare providers
across the country, which in turn can
accelerate learning in this vital area of
patient safety. Public comment has been
received on a version 0.1 of the CFER–
DS, and an Expert Panel convened by
the National Quality Forum (NQF) is
currently in the process of reviewing the
public comments and providing
feedback to AHRQ.
Federally listed PSOs can meet the
requirement to collect patient safety
work product in a standardized manner
to the extent practical and appropriate
by using AHRQ’s Common Formats. The
Common Formats are also available in
the public domain to encourage their
widespread adoption. An entity does
not need to be listed as a PSO or
working with one to use the Common
Formats. However, the Federal privilege
and confidentiality protections only
apply to information developed as
patient safety work product by
providers and PSOs working under the
Patient Safety Act.
Each version of the Common Formats
is released with accompanying technical
specifications, intended to provide
direction to software developers and to
PSOs that plan to submit data to the
Patient Safety Organization Privacy
Protection Center (PSOPPC) to ensure
non-identification for transmission to
the NPSD. For existing Common
Formats for Event Reporting, technical
specifications include the following:
• Data dictionary—defines data
elements and their attributes (data
element name, answer values, field

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length, guide for use, etc.) included in
Common Formats;
• Clinical document architecture
(CDA) implementation guide—provides
instructions for developing a file to
transmit the data from the PSO to the
PSOPPC using the Common Formats;
• Validation rules and errors
document—specifies and defines the
validation rules that will be applied to
the Common Formats data elements
submitted to the PSOPPC;
• Common Formats flow charts—
diagrams the valid paths to complete the
formats (a complete event report);
• Local specifications—provides
specifications for processing, linking,
and reporting on events and details
specifications for reports; and
• Metadata registry—includes
descriptive facts about information
contained in the data dictionary to
illustrate how such data corresponds
with similar data elements used by
other Federal agencies and standards
development organizations (e.g., HL—7,
International Standards Organization
(ISO)).
Agenda, Registration, and Other
Information About the Meeting
The December 16, 2021 meeting will
be an interactive forum designed to
allow meeting participants not only to
provide input but also to respond to the
input provided by others. The meeting
agenda will include: An update of
Federal efforts related to the PSO
Program and Common Formats;
discussion of the CFER–DS, including
requesting feedback on planned
technical support materials and general
integration/implementation; and,
planning for future meetings, including
discussing potential topics of interest
for regular future meetings with
software developers. AHRQ requests
that interested persons send an email to
SDMeetings@infinityconferences.com
for registration information. Before the
meeting, an agenda and logistical
information will be provided to
registrants. Prior to the meeting, AHRQ
invites review of the CFER–DS which
can be accessed through NQF’s website
at https://www.qualityforum.org/
Common_Formats_for_Patient_Safety_
Data.aspx.

[FR Doc. 2021–24888 Filed 11–15–21; 8:45 am]

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Agency for Toxic Substances and
Disease Registry
[60 Day–2–0059; Docket No. ATSDR–2021–
0008]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Agency for Toxic
Substances and Disease Registry
(ATSDR), 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 Per-orPolyfluoroalkyl Substances Exposure
Assessments (PFAS EAs). This Revision
information collection request (ICR) will
allow ATSDR/NCEH to continue to
conduct additional Exposure
Assessments (EAs) that may be
requested at military or non-military
installations.
DATES: ATSDR must receive written
comments on or before January 18,
2022.
ADDRESSES: You may submit comments,
identified by Docket No. ATSDR–2021–
0008 by any 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. ATSDR will post,
without change, all relevant comments
to Regulations.gov.
SUMMARY:

Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

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,

FOR FURTHER INFORMATION CONTACT:

Dated: November 9, 2021.
Marquita Cullom,
Associate Director.
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Federal Register / Vol. 86, No. 218 / Tuesday, November 16, 2021 / Notices
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329; phone:
404–639–7118; 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
Per- or Polyfluoroalkyl Substances
Exposure Assessments (PFAS EAs)
(OMB Control No. 0923–0059, Exp. 06/
30/2022)—Revision—Agency for Toxic
Substances and Disease Registry
(ATSDR).

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Background and Brief Description
Per-or-polyfluoroalkyl substances
(PFAS) are contaminants that have
gained national prominence over the
last decade. PFAS are a large group of
man-made chemicals that have been
used in industry and consumer products
worldwide since the 1950s. Although
some PFAS are no longer produced in
the United States, many remain in the
environment and may impact people’s
health.
The Agency for Toxic Substances and
Disease Registry (ATSDR) and the

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National Center for Environmental
Health (NCEH) are requesting a threeyear revision information collection
request (ICR) to continue to conduct
PFAS exposure assessments (EAs) at
both military or non-military locations
known to have PFAS in drinking water,
groundwater, or any other sources of
water. Previously, ATSDR was approved
to conduct up to five EAs per year, for
which the agency completed a total of
eight. Currently, ATSDR is seeking
approval to conduct up to three EAs per
year for a maximum of seven additional
locations.
Originally authorized under the
National Defense Authorization Act
(NDAA) of 2018, ATSDR is also
mandated under the Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(CERCLA), commonly known as the
‘‘Superfund’’ Act, as amended by the
Superfund Amendments and
Reauthorization Act (SARA) of 1986, to
prevent or mitigate adverse human
health effects and diminished quality of
life resulting from the exposure to
hazardous substances in the
environment. NCEH can conduct EAs
under the authority of Section 301 of the
Public Health Service Act (42 U.S.C.
241).
The PFAS EAs are conducted using
statistical sampling to produce unbiased
estimates of exposure to PFAS in
communities living on or near the
chosen current or former military
installations. The number of
respondents per EA will vary, but we
expect the number to be approximately
395, and to be determined by specific
statistical methods.
The time burden associated with the
EAs include the following collections:
• Community Event Evaluation
Survey: ATSDR/NCEH will hold a
public meeting prior to the start of the
EA and attendees will be asked to
complete a five minute Community
Event Evaluation Survey. It is assumed
that 163 of the 250 attendees will
complete the survey at each EA site,
resulting in a burden of 41 hours for
three EAs.
• Household Eligibility Screener:
ATSDR/NCEH anticipates asking
approximately 269 adults in each
household at each EA site to complete
a five minute telephone script, resulting
in a burden of 66 hours for three EAs.
• Estimation of Number of EA
Respondents by Age Group: Based on
the criteria in the Household
Recruitment Phone Script, 149
households are assumed to provide the
target sample size of 395 respondents at
each EA site, with a total of 1,185
respondents for three EAs. Based on

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63391

2017 Census estimates of average
household size (2.5), and number of
adults (1.9), and children under 18 years
of age (0.6) in the household, we are
able to estimate the annual number of
respondents by age group as the
following for three EAs: 900 adults ≥18
years and 284 children (165 aged 3–11
years and 119 aged 12–17 years).
• Biological Testing Tracking: All of
the EAs use biological sampling for
PFAS (blood and urine). A biological
testing tracking form for the testing
event will be provided to ensure that all
appropriate forms are completed and all
biological samples are collected. The
testing will take 20 minutes, resulting in
a burden of 395 hours annually for three
EAs.
• Adult Consent for Biological
Testing: 300 adults at each EA site will
be administered a 10-minute consent
form for testing of blood and urine for
PFAS, resulting in a burden of 150
hours annually for three EAs.
• Parental Permission Form for
Biological Testing: A parental
permission form will be administered to
the parents of 284 children aged 3–17
years for testing of blood and urine. The
parental permission form will take 10
minutes resulting in a burden of 47
hours annually for three EAs.
• Child Assent Form for Biological
Testing: Children aged 12–17 years
(119) will assent to the testing of blood
and urine for PFAS. The child assent
form will take approximately 10
minutes, resulting in a burden of 20
hours annually for three EAs.
• Adult Exposure Questionnaire for
Biological and Environmental Testing:
300 adults at each EA site will be
administered an exposure
questionnaire. The time associated with
administering the questionnaire and
completing the biological sampling is
approximately 30 minutes, resulting in
a burden of 450 hours annually for three
EAs.
• Parent Proxy for Child Exposure
Questionnaire for Biological Testing:
165 parents will respond to the 15minute questionnaire for their children,
3–11 years, resulting in a burden of 41
hours annually for three EAs.
• Child Exposure Questionnaire for
Biological Testing: Annually, 119
children will respond to the 15-minute
child questionnaire for themselves (age
12–17 years), resulting in a burden of 30
hours annually for three EAs.
• Household Recruitment Script for
Environmental Testing: ATSDR/NCEH
will administer a five minute
environmental recruitment script to 69
heads of households, resulting in a
burden of six hours annually for three
EAs.

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63392

Federal Register / Vol. 86, No. 218 / Tuesday, November 16, 2021 / Notices

• Consent for Environmental Testing:
ATSDR/NCEH will obtain consent to
test 10% of EA households for tap water
and indoor dust samples using a 10minute consent form for an annual total
of 45 households, resulting in burden of
eight hours annually for three EAs.

Environmental Sample Collection:
ATSDR/NCEH will complete sampling
at 45 households for three EAs deemed
eligible for the EA for testing of tap
water and indoor dust samples. The
sampling will take 30 minutes, for an

estimated burden of 23 hours annually
for three EAs.
ATSDR estimates the annualized time
burden is 1,277 hours. Participation is
voluntary, and there are no costs to
participants other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
hours

Form name

EA Community Members ......
EA Participants (all ages) .....
EA Adults ..............................

Community Event Evaluation Survey ..........
Biological Testing Tracking ..........................
Household Eligibility Screener .....................
Consent ........................................................
Exposure Questionnaire (Adult) for Biological and Environmental Testing.
Parental Permission .....................................
Exposure Questionnaire (Child) for Biological Testing (Parent Proxy).
Assent ..........................................................
Exposure Questionnaire (Child) for Biological Testing (Child completed).
Household Recruitment Script for Environmental Sampling.
Environmental Sampling Consent Form ......
Environmental Sample Collection Form ......

489
1,185
807
900
900

1
1
1
1
1

5/60
20/60
5/60
10/60
30/60

41
395
66
150
450

284
165

1
1

10/60
15/60

47
41

119
119

1
1

10/60
15/60

20
30

69

1

5/60

6

45
45

1
1

10/60
30/60

8
23

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

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

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

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

1,277

EA Parents ............................
EA Children ...........................
EA Heads-of-Households ......

Total ...............................

Jeffrey M. Zirger,
Lead,Information Collection Review
Office,Office of Scientific Integrity,Office of
Science,Centers for Disease Control and
Prevention.
[FR Doc. 2021–24992 Filed 11–15–21; 8:45 am]
BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[30Day–22–0047]

Agency Forms Undergoing Paperwork
Reduction Act Review

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Number of
respondents

Type of respondents

In accordance with the Paperwork
Reduction Act of 1995, the Agency for
Toxic Substances and Disease Registry
(ATSDR) has submitted the information
collection request titled ‘‘Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery’’ to the Office of Management
and Budget (OMB) for review and
approval. ATSDR previously published
a ‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on March 26,
2021, to obtain comments from the
public and affected agencies. ATSDR
did not receive comments related to the
previous notice. This notice serves to

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allow an additional 30 days for public
and affected agency comments.
ATSDR will accept all comments for
this proposed information collection
project. The Office of Management and
Budget is particularly interested in
comments that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.

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Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Generic Clearance for the Collection
of Qualitative Feedback on Agency
Service Delivery (OMB Control No.
0923–0047, Exp. 01/31/2022)—
Extension—Agency for Toxic
Substances and Disease Registry
(ATSDR).
Background and Brief Description
The information collection activity
provides a means to garner qualitative
customer and stakeholder feedback in
an efficient, timely manner, in
accordance with the Federal
government’s commitment to improving
service delivery. By qualitative feedback
we mean information that provides

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