60-day Federal Register Notice

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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
prevention of adverse health effects
when lead exposures occur in children,
through improved program management
and oversight in respondent
jurisdictions. The goal of the NIOSH
Adult Blood Lead Epidemiology and
Surveillance (ABLES) Program is to
build state capacity for adult blood lead
surveillance programs to measure trends
in adult blood lead levels and to prevent
lead over-exposures. Thus, blood lead
surveillance over the human lifespan is
covered under this single information
collection request (ICR), specifically for
children younger than 16 years through
CBLS at NCEH, and for adults 16 years
and older, through ABLES at NIOSH.
NCEH has a three-year cooperative
agreement, titled ‘‘Lead Poisoning
Prevention—Childhood Lead Poisoning
Prevention—financed partially by
Prevention and Public Health Funds’’—
(Funding Opportunity Announcement
[FOA] No. CDC–RFA–EH17–
1701PPHF17) and a two-year
cooperative agreement, titled
‘‘Childhood Lead Poisoning Prevention
Projects, State and Local Childhood
Lead Poisoning Prevention and
Surveillance of Blood Lead Levels in
Children’’—(Notice of Funding

Opportunity [NOFO] No. CDC–RFA–
EH18–1806). Both have one-year
extensions (CDC–RFA–EH17–
1701SUPP20 and CDC–RFA–EH18–
1806 SUPP20, respectively). The first
year of this ICR will extend through the
first eight months of the FY21 and thus
will be covered by the aforementioned
one-year extensions, while the second
and third years of this ICR will be
considered in future fiduciary
appraisals. States voluntarily participate
by sharing adult BLL data received from
testing laboratories with NIOSH ABLES.
Over the past several decades there
have been substantial efforts in
environmental lead abatement,
improved protection from occupational
lead exposure, and a reduction in the
prevalence of population blood lead
levels (BLLs) over time. The U.S.
population BLLs have substantially
decreased over the last four decades. For
example, the CDC has reported the
1976–1980 U.S. mean BLL in children
six months to five years was 16.0
micrograms per deciliter (mcg/dL), and
14.1 mcg/dL among adults 18 to 74
years. More recently, the CDC reported
the 2009–2010 U.S. BLL geometric
means among children one to five years

and among adults 20 years and older as
1.2 mcg/dL for both age groups.
In 2012, the National Toxicology
Program (NTP) concluded that there is
sufficient evidence that even BLLs less
than 5 mcg/dL are associated with
adverse health effects in both children
and adults. Despite the reduction in the
overall population BLL over four
decades, lead exposures continue to
occur at unacceptable levels for
individuals in communities and
workplaces across the nation.
Surveillance will continue through
CBLS and ABLES to identify cases of
elevated BLLs when primary prevention
is not achieved. As of 2015, NCEH
defines its blood lead reference level for
children as 5 mcg/dL. NIOSH defines an
elevated BLLs as greater than or equal
to 5 mcg/dL for adults.
Respondents are defined as state,
local, and territorial health departments
with lead poisoning prevention
programs. The estimated annual time
burden for NCEH CBLS is 946 hours.
The estimated annual time burden for
NIOSH ABLES is 280 hours. In total,
CDC is requesting approval for a total
annual time burden of 1,226 hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses
per
respondent

Average
burden
per response
(in hours)

Type of respondents

Form name

State or Local Health Departments, or their
Bona Fide Agents.

CBLS Variables (ASCII Text Files) ................

59

4

4

CBLS Aggregate Records Form (Excel) ........
ABLES Case Records Form ..........................
ABLES Aggregate Records Form ..................

1
32
8

1
1
1

2
8
3

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–05116 Filed 3–11–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–2021–0556; Docket No. CDC–2021–
0022]

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:

VerDate Sep<11>2014

17:04 Mar 11, 2021

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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
continuing information collection
project titled Assisted Reproductive
Technology (ART) Program Reporting
System. This study is designed to
collect information on ART cycles to
publish information on pregnancy
success rates as required under Section
2(a) of the Federal Clinic Success Rate
and Certification Act (FCSRCA).

SUMMARY:

CDC must receive written
comments on or before May 11, 2021.

DATES:

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You may submit comments,
identified by Docket No. CDC–2021–
0022 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–D74, 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
ADDRESSES:

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14118

Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices

instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; Email: [email protected].
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; and
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.
5. Assess information collection costs.

SUPPLEMENTARY INFORMATION:

Proposed Project
Assisted Reproductive Technology
(ART) Program Reporting System (OMB
Control No. 0920–0556, Exp. 8/31/
2021)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 2(a) of Public Law 102–493
(known as the Fertility Clinic Success
Rate and Certification Act of 1992
(FCSRCA), 42 U.S.C. 263a–1(a)) requires
that each assisted reproductive
technology (ART) program shall
annually report to the Secretary through
the Centers for Disease Control and
Prevention:(1) Pregnancy success rates
achieved by such ART program, and (2)
the identity of each embryo laboratory
used by such ART program and whether
the laboratory is certified or has applied
for such certification under the Act. The
required information is currently
reported by ART programs to CDC as
specified in the Assisted Reproductive
Technology (ART) Program Reporting
System (OMB Control No. 0920–0556,
Exp. 8/31/2021). CDC seeks to extend
OMB approval for a period of three
years.
The currently approved program
reporting system, also known as the
National ART Surveillance System
(NASS), includes information about all
ART cycles initiated by any of the ART
programs in the United States. The start
of an ART cycle is considered when a
woman begins taking medication to
stimulate egg production or begins
monitoring with the intent of having
embryos transferred. For each cycle,
CDC collects information about the
pregnancy outcome, as well as a number
of data items deemed by experts in the
field to be important to explain
variability in success rates across ART
programs and individuals.
Each ART program reports its annual
ART cycle data to CDC in midDecember. The annual data reporting
consists of information about all ART
cycles that were initiated in the

previous calendar year. For example,
the December 2020 reports described
ART cycles that were initiated between
January 1, 2018, and December 31, 2018.
Data elements and definitions currently
in use reflect CDC’s prior consultations
with representatives of the Society for
Assisted Reproductive Technology
(SART), the American Society for
Reproductive Medicine, and RESOLVE:
The National Infertility Association (a
national, nonprofit consumer
organization), as well as a variety of
individuals with expertise and interest
in this field.
The estimated number of respondents
(ART programs or clinics) is 456, based
on the number of clinics that provided
information in 2018; the estimated
average number of responses (ART
cycles) per respondent is 670. The total
burden estimate is higher than the
previous approval due to an increase in
the utilization of ART in the United
States and, thus, an increase in the
number of ART cycles on which
respondents report. Additionally,
approximately 5–10% of responding
clinics will be randomly selected each
year to participate in data validation
and quality control activities; an
estimated 35 clinics will be selected to
report validation data on 70 cycles each
on average. Finally, respondents may
provide feedback to CDC about the
usability and utility of the reporting
system. The option to participate in the
feedback survey is presented to
respondents when they complete their
required data submission. Participation
in the feedback survey is voluntary and
is not required by the FCSRCA. CDC
estimates that 50% of ART programs
will participate in the feedback survey.
The collection of ART cycle
information allows CDC to publish an
annual report to Congress as specified
by the FCSRCA and to provide
information needed by consumers. OMB
approval is requested for three years.
CDC requests approval for 219,904
annual burden hours. There are no costs
to respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

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

VerDate Sep<11>2014

Number of
respondents

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

NASS Reporting Form .................................
Data Validation .............................................
Feedback Survey .........................................

456
35
255

670
70
1

43/60
23/60
2/60

218,956
939
9

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

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

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

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

219,904

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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–05115 Filed 3–11–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–2021–0740; Docket No. CDC–2021–
0028]

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 Medical Monitoring Project
(MMP). The purpose of this data
collection is to describe the healthrelated behaviors, experiences and
needs of adults diagnosed with HIV in
the United States. Data will be used to
guide national and local HIV-related
service organization and delivery, and
monitor receipt of HIV treatment and
prevention services and clinical
outcomes.

SUMMARY:

CDC must receive written
comments on or before May 11, 2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0028 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–D74, 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
DATES:

VerDate Sep<11>2014

17:04 Mar 11, 2021

Jkt 253001

(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–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; Email: [email protected].
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; and
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.
5. Assess information collection costs.

SUPPLEMENTARY INFORMATION:

Proposed Project
Medical Monitoring Project (MMP)
(OMB Control No. 0920–0740, Exp. 6/
30/2021)—Revision—National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).

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14119

Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), Division of HIV/AIDS
Prevention (DHAP) requests a revision
of the currently approved Information
Collection Request: ‘‘Medical
Monitoring Project’’ which expires June
30, 2021. This data collection addresses
the need for national estimates of access
to, and utilization of HIV-related
medical care and services, the quality of
HIV-related ambulatory care, and HIVrelated behaviors and clinical outcomes.
For the proposed project, the same
data collection methods will be used as
for the currently approved project. Data
would be collected from a probability
sample of HIV-diagnosed adults in the
U.S. who consent to an interview and
abstraction of their medical records. As
for the currently approved project,
deidentified information would also be
extracted from HIV case surveillance
records for a dataset (referred to as the
minimum dataset), which is used to
assess non-response bias, for quality
control, to improve the ability of MMP
to monitor ongoing care and treatment
of HIV-infected persons, and to make
inferences from the MMP sample to
HIV-diagnosed persons nationally. No
other Federal agency collects such
nationally representative populationbased information from HIV-diagnosed
adults. The data are expected to have
significant implications for policy,
program development, and resource
allocation at the state/local and national
levels.
The changes proposed in this request
update the data collection system to
meet prevailing information needs and
enhance the value of MMP data, while
remaining within the scope of the
currently approved project purpose. The
result is a 10% reduction in burden, or
a reduction of 647 total burden hours
annually. The reduction in burden was
a result of revisions to the interview
questionnaire that were made to
improve coherence, boost the efficiency
of the data collection, and increase the
relevance and value of the information,
which decreased the time of interview
from 45 minutes to 40 minutes.
Changes made, that did not affect the
burden, listed below:
• Non-substantive changes have been
made to the respondent consent form to
decrease the reading comprehension
level and make the form more visual.
• Nine data elements were removed
from, and three data elements were
added to the Minimum Dataset. Because
these data elements are extracted from
the HIV surveillance system from which
they are sampled, these changes do not
affect the burden of the project.

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