Proposed Data Collection Submitted for Public Comment and Recommendations, 14117-14119 [2021-05115]

Download as PDF 14117 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 Jkt 253001 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: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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: E:\FR\FM\12MRN1.SGM 12MRN1 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: 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; 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 17:04 Mar 11, 2021 Jkt 253001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\12MRN1.SGM 12MRN1 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: 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; 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). PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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. E:\FR\FM\12MRN1.SGM 12MRN1

Agencies

[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14117-14119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05115]


-----------------------------------------------------------------------

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

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 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).

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

ADDRESSES: 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

[[Page 14118]]

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].

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; 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.

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 mid-
December. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Number of    Average burden
              Type of respondents                            Form name                 Number of     responses per   per response     Total burden (in
                                                                                      respondents     respondent      (in hours)           hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 NASS Reporting Form..............             456             670           43/60               218,956
                                                 Data Validation..................              35              70           23/60                   939
                                                 Feedback Survey..................             255               1            2/60                     9
                                                                                   ---------------------------------------------------------------------
    Total......................................  .................................  ..............  ..............  ..............               219,904
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 14119]]

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


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