Proposed Data Collection Submitted for Public Comment and Recommendations, 34636-34637 [2020-12242]

Download as PDF 34636 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Average burden per response (in hours) Total burden (in hours) Form name State, Territory, and New Mexico County Officials. State, Territory, and other officials .... Monthly Vital Statistics Report ......... 91 12 8/60 146 Annual Vital Statistics Occurrence Report. 58 1 30/60 29 Total ........................................... .......................................................... ........................ ........................ ........................ 175 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–12243 Filed 6–4–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [60Day–20–20OT; Docket No. CDC–2020– 0063] 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 ‘‘Mycoplasma genitalium Treatment Failure Registry.’’ The purpose of the collection is to determine which second-line antibiotics are in use for M. genitalium treatment failure and monitor antibiotic resistance patterns for treatment failure cases throughout the United States. DATES: CDC must receive written comments on or before August 4, 2020. ADDRESSES: You may submit comments, identified by Docket No. CDC–2020– 0063 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 SUMMARY: VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 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. Centers for Disease Control and Prevention lotter on DSK9F5VC42PROD with NOTICES Number of responses per respondent Number of respondents Type of respondents 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: 404–639–7570; 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, FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 Mycoplasma genitalium Treatment Failure Registry—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC), Division of STD Prevention requests a three-year approval of an information collection request for the Mycoplasma genitalium Treatment Failure Registry, which will entail use of a standardized Case Report Form. The primary goal of this activity is to establish a registry to monitor cases of Mycoplasma genitalium (M. genitalium) treatment failure in the United States. The project objectives are as follows: (1) Using existing clinical data, describe demographic and behavioral factors among patients with documented Mycoplasma genitalium who fail current CDC-recommended treatment. (2) Using existing clinical data, describe antibiotic regimens utilized among patients with Mycoplasma genitalium treatment failure, including documentation of clinical and microbiologic cure. (3) Using existing laboratory specimens, monitor genetic mutations associated with macrolide or fluroquinolone antibiotic resistance. Data captured on the standardized Case Report Form will be analyzed to determine outcomes from usage of second-line antibiotic therapy for M. E:\FR\FM\05JNN1.SGM 05JNN1 34637 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices gentialium. These data may inform future CDC STD Treatment Guidelines. There are an estimated 100 respondents (anticipated to report once per year) who will be clinicians in private and public health care settings. The data collection is necessary as there are no current national clinically effective, as well as determining antibiotic resistance patterns of M. genitalium throughout the US. There are no costs to respondents other than their time. The estimated annualized burden hours for this data collection are 100 hours. recommendations for patients who fail current CDC-recommended therapy for M. genitalium. Each case report form is anticipated to take up to 60 minutes to complete. This data collection provides CDC with information to determine which second-line treatments are most ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Physician or Nurse Practitioner. Number of respondents Form name M. genitalium Treatment Failure Registry Case Report Form. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–12242 Filed 6–4–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Review and Technical Assistance Process (New Collection) Children’s Bureau, Administration for Children and Families, HHS. ACTION: Request for public comment. AGENCY: The Children’s Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to establish a generic clearance to collect information to assess regulatory requirements of title IV–E agencies’ Comprehensive Child Welfare Information System (CCWIS) SUMMARY: Number responses per respondent 100 and ensure that the CCWIS is utilized for purposes consistent with the efficient, economical, and effective administration of the title IV–B and IV– E plans. The information collected is intended to be used for review and technical assistance processes. DATES: Comments due within 60 days of publication. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above. ADDRESSES: Copies of the proposed collection of information can be obtained and comments may be forwarded by emailing infocollection@ acf.hhs.gov. Copies can also be obtained by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation (OPRE), 330 C Street SW, Washington, DC 20201, Attn: ACF Reports Clearance Officer. All requests, emailed or written, should be identified by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: This initial request is to establish an overarching generic for CCWIS Review and Technical Assistance (TA) information collections and includes six initial TA tools for title 1 Average burden per response (in hours) Total burden hours 1 100 IV–E agencies to self-assess their conformity to CCWIS project and design requirements at 45 CFR 1355.52–3. The initial six TA tools include intake, investigation, case management, adoption, foster care and service provider management, and administration. In the future, ACF will submit under this generic clearance mechanism additional TA tools for title IV–E agencies to self-assess design, data quality, usability, reporting, data exchanges, external systems, eligibility, finance, Child Welfare Contributing Agencies, and other tools, as needed, to assess new child welfare programs and modern system architecture. The CCWIS requirements at 45 CFR 1355.55 require the review, assessment, and inspection of the planning, design, development, installation, operation, and maintenance of each CCWIS project on a continuing basis. The Advance Planning Document regulations at 45 CFR 95.621 require periodic reviews of state and local agency methods and practices to insure that information systems, including CCWIS, are utilized for purposes consistent with proper and efficient administration. Respondents: Title IV–E agencies under the Social Security Act. ANNUAL BURDEN ESTIMATES Total number of respondents lotter on DSK9F5VC42PROD with NOTICES Instrument CCWIS Self-Assessment—Intake .................................................................... CCWIS Self-Assessment—Investigation ......................................................... CCWIS Self-Assessment—Case Management ............................................... CCWIS Self-Assessment—Adoption ............................................................... CCWIS Self-Assessment—Foster Care and Service Provider Management CCWIS Self-Assessment—Administration ....................................................... Future Tools to be developed ......................................................................... VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Total number of responses per respondent 55 55 55 55 55 55 55 E:\FR\FM\05JNN1.SGM 1 1 1 1 1 1 10 05JNN1 Average burden hours per response 10 10 10 10 10 10 12 Total burden hours 550 550 550 550 550 550 6,600

Agencies

[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34636-34637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12242]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20OT; Docket No. CDC-2020-0063]


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 proposed 
information collection project titled ``Mycoplasma genitalium Treatment 
Failure Registry.'' The purpose of the collection is to determine which 
second-line antibiotics are in use for M. genitalium treatment failure 
and monitor antibiotic resistance patterns for treatment failure cases 
throughout the United States.

DATES: CDC must receive written comments on or before August 4, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0063 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 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: 404-639-7570; 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

    Mycoplasma genitalium Treatment Failure Registry--New--National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), Division of 
STD Prevention requests a three-year approval of an information 
collection request for the Mycoplasma genitalium Treatment Failure 
Registry, which will entail use of a standardized Case Report Form.
    The primary goal of this activity is to establish a registry to 
monitor cases of Mycoplasma genitalium (M. genitalium) treatment 
failure in the United States. The project objectives are as follows: 
(1) Using existing clinical data, describe demographic and behavioral 
factors among patients with documented Mycoplasma genitalium who fail 
current CDC-recommended treatment. (2) Using existing clinical data, 
describe antibiotic regimens utilized among patients with Mycoplasma 
genitalium treatment failure, including documentation of clinical and 
microbiologic cure. (3) Using existing laboratory specimens, monitor 
genetic mutations associated with macrolide or fluroquinolone 
antibiotic resistance. Data captured on the standardized Case Report 
Form will be analyzed to determine outcomes from usage of second-line 
antibiotic therapy for M.

[[Page 34637]]

gentialium. These data may inform future CDC STD Treatment Guidelines.
    There are an estimated 100 respondents (anticipated to report once 
per year) who will be clinicians in private and public health care 
settings. The data collection is necessary as there are no current 
national recommendations for patients who fail current CDC-recommended 
therapy for M. genitalium. Each case report form is anticipated to take 
up to 60 minutes to complete.
    This data collection provides CDC with information to determine 
which second-line treatments are most clinically effective, as well as 
determining antibiotic resistance patterns of M. genitalium throughout 
the US. There are no costs to respondents other than their time. The 
estimated annualized burden hours for this data collection are 100 
hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                      Number      Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Physician or Nurse              M. genitalium                100               1               1             100
 Practitioner.                   Treatment
                                 Failure
                                 Registry Case
                                 Report Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-12242 Filed 6-4-20; 8:45 am]
 BILLING CODE 4163-18-P


This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.