60d FRN - published SEP2021

51894

Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices

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. 2021–20152 Filed 9–16–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee (CLIAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Clinical Laboratory Improvement
Advisory Committee (CLIAC). This
meeting is open to the public, limited
only by the webcast lines available.
Check the CLIAC website on the day of
the meeting for the web conference link
www.cdc.gov/cliac.
DATES: The meeting will be held on
November 3, 2021, from 11:00 a.m. to
6:00 p.m., EDT, and November 4, 2021,
from 11:00 a.m. to 6:00 p.m., EDT.
ADDRESSES: This is a virtual meeting.
Meeting times are tentative and subject
to change. The confirmed meeting
times, agenda items, and meeting
materials including instructions for
accessing the live meeting broadcast
will be available on the CLIAC website
at www.cdc.gov/cliac.
FOR FURTHER INFORMATION CONTACT:
Nancy Anderson, MMSc, MT(ASCP),
Senior Advisor for Clinical Laboratories,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4027,
Telephone: (404) 498–2741;
[email protected].
SUPPLEMENTARY INFORMATION:
Purpose: This Committee is charged
with providing scientific and technical
advice and guidance to the Secretary,
HHS; the Assistant Secretary for Health;
SUMMARY:

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the Director, CDC; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare and Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and
laboratory medicine practice and
specific questions related to possible
revision of the Clinical Laboratory
Improvement Amendments of
1988(CLIA) standards. Examples
include providing guidance on studies
designed to improve safety,
effectiveness, efficiency, timeliness,
equity, and patient-centeredness of
laboratory services; revisions to the
standards under which clinical
laboratories are regulated; the impact of
proposed revisions to the standards on
medical and laboratory practice; and the
modification of the standards and
provision of non-regulatory guidelines
to accommodate technological
advances, such as new test methods, the
electronic transmission of laboratory
information, and mechanisms to
improve the integration of public health
and clinical laboratory practices.
Matters To Be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. In addition to the
general updates, agency presentations
will include an overview of the FDA’s
Center for Biologics Evaluation and
Research, a laboratory safety update,
and a status report on the new CLIA
regulations assessment workgroup.
Presentations and CLIAC discussion
will focus on next generation
sequencing in clinical and public health
laboratories and laboratory data
exchange and harmonization. Agenda
items are subject to change as priorities
dictate.
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments
pertinent to agenda items. Public
comment periods for each agenda item
are scheduled immediately prior to the
Committee discussion period for that
item. In general, each individual or
group requesting to present an oral
comment will be limited to a total time
of five minutes (unless otherwise
indicated). Speakers should email
[email protected] or notify the contact
person at least five business days prior
to the meeting date. For individuals or
groups unable to attend the meeting,
CLIAC accepts written comments until
the date of the meeting (unless
otherwise stated). However, it is
requested that comments be submitted
at least five business days prior to the
meeting date so that the comments may
be made available to the Committee for
their consideration and public

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distribution. All written comments will
be included in the meeting Summary
Report posted on the CLIAC website.
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. 2021–20151 Filed 9–16–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–1274; Docket No. CDC–2021–
0096]

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 the
Million Hearts Hospital & Health
System Recognition Program. This
program recognizes institutions working
systematically to improve the
cardiovascular health of the population
and communities they serve.
DATES: CDC must receive written
comments on or before November 16,
2021.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2021–
0096 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

ADDRESSES:

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Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices
Clifton Road NE, Mailstop 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,
Mailstop H21–8, Atlanta, Georgia 30329;
phone: 404–639–7570; Email: omb@
cdc.gov.
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.

SUPPLEMENTARY INFORMATION:

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Proposed Project
Million Hearts Hospitals & Health
Systems Recognition Program (OMB
Control No. 0920–1274, Exp. 11/30/
2022)—Extension—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Heart disease, stroke and other
cardiovascular diseases (CVDs) kill over
800,000 Americans each year,
accounting for one in every three
deaths. CVD is the nation’s number one
killer among both men and women, and
the leading cause of health disparities.
Million Hearts, a national, publicprivate initiative co-led by the Centers
for Disease Control and Prevention
(CDC) and the Centers for Medicare &
Medicaid Services (CMS), was
established to address this issue.
Whether migrating towards value-based
reimbursement or simply striving for a
significant impact in reducing the
devastation of heart attacks and strokes,
clinical organizations are positioned to
improve the health of the population
they serve by implementing highimpact, evidence-based strategies.
Achieving a Million Hearts Hospitals &
Health Systems designation signals a
commitment to not only clinical quality,
but population health overall.
Initially launched in 2020, the
Program will continue to recognize
institutions that are working to
systematically improve the
cardiovascular health of the population
and communities that they serve by
implementing strategies under the
Million Hearts priority areas of Keeping
People Healthy, Optimizing Care,
Improving Outcomes for Priority
Populations, and Innovating for Health.
CDC anticipates that new applicants
will range from health systems with
multiple hospitals, hospitals with and
without ambulatory medical practices,
and medical practices not affiliated with
hospitals. Any clinical entity whose
leaders consider it eligible may apply.
Recognition can be achieved by a
robust commitment to implement
specific strategies, by implementing
specific strategies, and most
importantly, by achieving specific
outcomes. Applicants will complete the
Million Hearts Hospitals & Health
Systems Recognition Program
application, indicating the areas in
which they are committing to
implement Million Hearts strategies;
areas in which they have implemented
key strategies; and those strategies for
which they have achieved outcomes/
results.

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51895

Applicants must address a minimum
of one strategy in at least three of the
four priority areas (Keeping People
Healthy, Optimizing Care, Improving
Outcomes for Priority Populations and
Innovating for Health) that are outlined
in the application. However, they are
encouraged to target as many strategies
as is appropriate for their institution.
Applicants will be subject to a
background check.
The Million Hearts Hospitals and
Health Systems designation conveys
that the institution is committed to
preventing heart attacks and strokes by
a combination of efforts that are about
Keeping People Healthy, Optimizing
Care, Improving Outcomes for Priority
Populations and Innovating for Health.
All applicants with reported outcomes
and a select number of those who are
committing to implement, or are
implementing Million Hearts strategies,
will be asked to participate in a semistructured, qualitative interview. The
purpose of the interview is to obtain indepth contextual information about the
Million Hearts strategies and facilitators
used to achieve improved
cardiovascular outcomes among the
applicant’s patient population.
Applicants with reported outcomes will
receive increased recognition from
Million Hearts by having their success
stories highlighted by Million Hearts by
placement on the Million Hearts website
or e-newsletter.
The program’s web-based application
will stay open throughout the year and
applications will be reviewed on a
quarterly basis and recognized within
six months of acceptable review. CDC
estimates that information will be
collected from up to 50 applicants per
year. The overall goal of the Million
Hearts initiative is to prevent one
million heart attacks and strokes.
Promoting evidence-based strategies
that prevent CVD is an additional focus
of the initiative.
CDC will use the information
collected through the Million Hearts
Hospitals & Health Systems Recognition
Program to increase widespread
attention on successful and sustainable
implementation strategies, improve
understanding of these strategies at the
practice level, bring visibility to
organizations that commit, implement,
or have implemented Million Hearts
strategies and motivate other hospitals
and health systems to strengthen their
efforts to address CVD.
OMB approval is requested for three
years. CDC requests approval for an
estimated 149 annual burden hours.
Participation is voluntarily, and there
are no costs to respondents other than
their time.

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51896

Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Avg. burden
per response
(in hrs.)

Total burden
(in hrs.)

Type of respondents

Form name

Medical & Health Service Manager ..
Medical & Health Service Manager ..

Recognition Program Application .....
Interview Guide ................................

50
30

1
1

160/60
30/60

134
15

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

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

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

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

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

149

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–20156 Filed 9–16–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–0314]

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled The National
Survey of Family Growth (NSFG) to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on June 10, 2021 to obtain
comments from the public and affected
agencies. CDC received one nonsubstantive comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC 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

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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.
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
The National Survey of Family
Growth (NSFG) (OMB Control No.
0920–0314, Exp. 06/30/2021)—
Reinstatement with Change—National
Center for Health Statistics (NCHS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on ‘‘family formation, growth,
and dissolution,’’ as well as
‘‘determinants of health’’ and
‘‘utilization of health care’’ in the
United States. This information
collection request includes the data
collection in 2022–2024 for the
continuous National Survey of Family
Growth (NSFG).
The NSFG was conducted
periodically between 1973 and 2002,
continuously in 2006–2010, and after a
break of 15 months, continuously in

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2011–2019, by the National Center for
Health Statistics, CDC (CDC/NCHS). The
response rate during the 2011–2019 data
collection period ranged from 64.5–
74.0%, and the cumulative response
rate for this eight-year fieldwork period
was 67.7%.
The NSFG program produces
descriptive statistics which document
factors associated with birth and
pregnancy rates, including
contraception, infertility, marriage,
cohabitation, and sexual activity, in the
US household population 15–49 years
(15–44 prior to 2015), as well as
behaviors that affect the risk of HIV and
other sexually transmitted diseases
(STD). The survey also disseminates
statistics on the medical care associated
with contraception, infertility,
pregnancy, and related health
conditions.
NSFG data users include the DHHS
programs that fund the survey,
including CDC/NCHS and 11 others
within the Department of Health and
Human Services:
• Eunice Kennedy Shriver National
Institute for Child Health and Human
Development (NIH/NICHD)
• Office of Population Affairs (OPA)
• Children’s Bureau in the
Administration for Children and
Families (ACF/CB)
• Office of Planning, Research, and
Evaluation (ACF/CB)
• Office on Women’s Health (OASH/
OWH)
• CDC’s Division of HIV/AIDS
Prevention (CDC/NCHHSTP/DHAP)
• CDC’s Division of STD Prevention
(CDC/NCHHSTP/DSTDP)
• CDC’s Division of Adolescent and
School Health (CDC/NCHHSTP/
DASH)
• CDC’s Division of Reproductive
Health (CDC/NCCDPHP/DRH)
• CDC’s Division of Cancer Prevention
and Control (CDC/NCCDPHP/DCPC)
• CDC’s Division of Violence
Prevention (CDC/NCIPC/DVP)
The NSFG is also used by state and
local governments (primarily for
benchmarking to national data); private
research and action organizations
focused on men’s and women’s health,
child well-being, and marriage and the

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