Agency Forms Undergoing Paperwork Reduction Act Review, 35645-35646 [2018-16091]

Download as PDF Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices Prevention, and the Agency for Toxic Substances and Disease Registry. Administration of erdafitinib Administration of esketamine hydrochloride nasal spray, for intranasal use Administration of ERLEADATM (apalutamide), for oral use Dia Taylor, Acting Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2018–16102 Filed 7–26–18; 8:45 am] BILLING CODE 4160–18–P Addenda and Key Updates ICD–10–CM Topics Deep Vein Thrombosis Dravet Syndrome Latent Tuberculosis Infection Pressure ulcer of mucosal membrane by site ICD–10–CM Addendum Agenda items are subject to change as priorities dictate. Security Considerations: Due to increased security requirements, CMS has instituted stringent procedures for entrance into the building by nongovernment employees. Attendees will need to present valid government-issued picture identification, and sign-in at the security desk upon entering the building. Attendees who wish to attend the September 11–12, 2018, ICD–10–CM C&M meeting must submit their name and organization by September 3, 2018, for inclusion on the visitor list. This visitor list will be maintained at the front desk of the CMS building and used by the guards to admit visitors to the meeting. Participants who attended previous Coordination and Maintenance meetings will no longer be automatically added to the visitor list. You must request inclusion of your name prior to each meeting you wish attend. Please register to attend the meeting on-line at: https://www.cms.hhs.gov/ apps/events/. Please contact Mady Hue (410–786– 4510) or Marilu.hue@cms.hhs.gov for questions about the registration process. amozie on DSK3GDR082PROD with NOTICES1 Note: CMS and NCHS no longer provide paper copies of handouts for the meeting. Electronic copies of all meeting materials will be posted on the CMS and NCHS websites prior to the meeting at https:// www.cms.hhs.gov/ICD9Provider DiagnosticCodes/03_ meetings.asp#TopOfPage and https:// www.cdc.gov/nchs/icd/icd10cm_ maintenance.htm. The Director, Management Analysis and Services Office, 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 VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–18–0556] 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 Assisted Reproductive Technology (ART) Program Reporting System 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 May 10, 2018 to obtain comments from the public and affected agencies. CDC did not receive comments 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 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 35645 of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. 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 Assisted Reproductive Technology (ART) Program Reporting System (OMB No. 0920–0556, expires 7/31/2018)— 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 No. 0920–0556, exp. 7/ 31/2018). CDC seeks to extend OMB approval for a period of three years. The revised total burden estimate is lower than under the previous approval, due to removal of the burden associated with a one-time system upgrade that was completed under the prior approval. However, some of this burden reduction will be offset by an increase in the number of ART clinics and cycles reported, due to an increase in the utilization of ART in the United States. 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. An ART cycle is considered to begin when a woman begins taking ovarian stimulatory drugs or starts ovarian 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 E:\FR\FM\27JYN1.SGM 27JYN1 35646 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 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 2017 reports described ART cycles that were initiated between January 1, 2016, and December 31, 2016. 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 464, based on the number of clinics that provided information in 2015; the estimated average number of responses (ART cycles) per respondent is 350. 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 75% 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. The estimated annualized Burden Hours are 114,631 which is a decrease of 1,794 from the current OMB-approved collection. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name ART Clinics ..................................................... NASS .............................................................. Data Validation ............................................... Feedback Survey ........................................... Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2018–16091 Filed 7–26–18; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–18–0222] amozie on DSK3GDR082PROD with NOTICES1 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 Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER), 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 March 1, 2018 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 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 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 or send an email to omb@cdc.gov. Direct written comments and/or suggestions PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Number of responses per respondent 464 35 348 350 70 1 Average burden per response (in hours) 42/60 23/60 2/60 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 Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) (OMB Control Number 0920– 0222, Expiration 07/31/2018)— Revision—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 undertake and support (by grant or contract) research, demonstrations, and evaluations respecting new or improved methods for obtaining current data to support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States. The Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) is the focal point within NCHS for questionnaire and survey development, pre-testing, and evaluation activities for CDC surveys (such as the NCHS National Health E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35645-35646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16091]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0556]


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 Assisted Reproductive Technology (ART) 
Program Reporting System 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 
May 10, 2018 to obtain comments from the public and affected agencies. 
CDC did not receive comments 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 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 or send an email to [email protected]. 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

    Assisted Reproductive Technology (ART) Program Reporting System 
(OMB No. 0920-0556, expires 7/31/2018)--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 No. 0920-
0556, exp. 7/31/2018). CDC seeks to extend OMB approval for a period of 
three years. The revised total burden estimate is lower than under the 
previous approval, due to removal of the burden associated with a one-
time system upgrade that was completed under the prior approval. 
However, some of this burden reduction will be offset by an increase in 
the number of ART clinics and cycles reported, due to an increase in 
the utilization of ART in the United States.
    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. 
An ART cycle is considered to begin when a woman begins taking ovarian 
stimulatory drugs or starts ovarian 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

[[Page 35646]]

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 2017 reports described ART cycles that were 
initiated between January 1, 2016, and December 31, 2016. 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 
464, based on the number of clinics that provided information in 2015; 
the estimated average number of responses (ART cycles) per respondent 
is 350. 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 75% 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. The estimated annualized Burden Hours are 114,631 which is a 
decrease of 1,794 from the current OMB-approved collection. 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
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
ART Clinics...........................  NASS....................             464             350           42/60
                                        Data Validation.........              35              70           23/60
                                        Feedback Survey.........             348               1            2/60
----------------------------------------------------------------------------------------------------------------


 Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-16091 Filed 7-26-18; 8:45 am]
 BILLING CODE 4163-18-P


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