83 FR 5102 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 24 (February 5, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 24 (February 5, 2018)
| Page Range | 5102-5103 | |
| FR Document | 2018-02222 |
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)] [Notices] [Pages 5102-5103] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02222] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-0307; Docket No. CDC-2018-0019] 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 ``Gonococcal Isolate Surveillance Project (GISP)''. The purpose of GISP is to monitor trends in antimicrobial resistance in N. gonorrhoeae strains in the United States in order to establish a scientific basis for the selection of gonococcal therapies and to allow proactive changes to treatment guidelines before widespread resistance and failures of treatment occur. DATES: CDC must receive written comments on or before April 6, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0019 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Leroy A. Richardson, 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 Leroy A. Richardson, 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 Gonococcal Isolate Surveillance Project (OMB Control Number 0920- 0307, Expiration 2/28/2019)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Gonococcal Isolate Surveillance Project (GISP) was created in 1986 to monitor trends in antimicrobial susceptibilities of N. gonorrhoeae strains in the United States. Data from GISP are used to establish a scientific basis for the selection of gonococcal therapies and to allow pro-active changes to treatment guidelines before widespread resistance and failures of treatment occur. To increase capacity to detect and monitor resistant gonorrhea and improve the specificity of GISP, this submission is a revision to include collection of additional isolates and data elements. The Centers for Disease Control and Prevention has designated N. gonorrhoeae as one of three ``urgent'' antibiotic resistance threats in the United States. The CDC is requesting a three-year OMB approval for this revision, which directly responds to the [[Page 5103]] National Strategy for Combating Antibiotic Resistant Bacteria by improving and strengthening surveillance of antimicrobial resistance through GISP. Additionally, data from GISP will also allow CDC to monitor and evaluate the effectiveness of public health interventions conducted to support the National Strategy for Combating Antibiotic Resistant Bacteria. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hours) respondent hours) ---------------------------------------------------------------------------------------------------------------- Sentinel site conducting core Demographic/ 20 240 11/60 880 surveillance. Clinical Data. Sentinel site conducting Demographic/ 10 840 12/60 1,680 enhanced surveillance. Clinical Data. Regional laboratory........... Antimicrobial 4 3,300 40/60 8,800 Susceptibility Testing Results. Regional laboratory........... Control Strain 4 48 5/60 16 Susceptibility Testing. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 11,376 ---------------------------------------------------------------------------------------------------------------- Leroy A. Richardson, 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. 2018-02222 Filed 2-2-18; 8:45 am] BILLING CODE 4163-18-P
![5102 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
respondents other than their time. The total estimated annualized burden hours
are 38.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Type of respondents Form name respondents per response
respondent (in hours)
State Public Health Director ........................... Interview Guide .............................................. 6 1 75/60
State Public Health Manager .......................... Interview Guide .............................................. 11 1 75/60
State Medicaid Director .................................. Interview Guide .............................................. 6 1 75/60
State Medicaid Manager ................................. Interview Guide .............................................. 6 1 75/60
Leroy A. Richardson, • Federal eRulemaking Portal: whether the information will have
Chief, Information Collection Review Office, Regulations.gov. Follow the instructions for practical utility;
Office of Scientific Integrity, Office of the submitting comments. 2. Evaluate the accuracy of the
Associate Director for Science, Office of the • Mail: Leroy A. Richardson, Information agency’s estimate of the burden of the
Director, Centers for Disease Control and Collection Review Office, Centers for Disease
proposed collection of information,
Prevention. Control and Prevention, 1600 Clifton Road
NE, MS–D74, Atlanta, Georgia 30329. including the validity of the
[FR Doc. 2018–02205 Filed 2–2–18; 8:45 am] methodology and assumptions used;
BILLING CODE 4163–18–P Instructions: All submissions received 3. Enhance the quality, utility, and
must include the agency name and clarity of the information to be
Docket Number. CDC will post, without collected; and
DEPARTMENT OF HEALTH AND change, all relevant comments to 4. Minimize the burden of the
HUMAN SERVICES Regulations.gov. collection of information on those who
Please note: Submit all comments through are to respond, including through the
Centers for Disease Control and the Federal eRulemaking portal use of appropriate automated,
Prevention (regulations.gov) or by U.S. mail to the electronic, mechanical, or other
[60Day–18–0307; Docket No. CDC–2018– address listed above. technological collection techniques or
0019]
FOR FURTHER INFORMATION CONTACT: To other forms of information technology,
request more information on the e.g., permitting electronic submissions
Proposed Data Collection Submitted of responses.
for Public Comment and proposed project or to obtain a copy of
5. Assess information collection costs.
Recommendations the information collection plan and
instruments, contact Leroy A. Proposed Project
AGENCY: Centers for Disease Control and Richardson, Information Collection Gonococcal Isolate Surveillance
Prevention (CDC), Department of Health Review Office, Centers for Disease Project (OMB Control Number 0920–
and Human Services (HHS). Control and Prevention, 1600 Clifton 0307, Expiration 2/28/2019)—
ACTION: Notice with comment period. Road NE, MS–D74, Atlanta, Georgia Revision—National Center for HIV/
30329; phone: 404–639–7570; Email: AIDS, Viral Hepatitis, STD, and TB
SUMMARY: The Centers for Disease omb@cdc.gov.
Control and Prevention (CDC), as part of Prevention (NCHHSTP), Centers for
SUPPLEMENTARY INFORMATION: Under the Disease Control and Prevention (CDC).
its continuing effort to reduce public Paperwork Reduction Act of 1995 (PRA)
burden and maximize the utility of (44 U.S.C. 3501–3520), Federal agencies Background and Brief Description
government information, invites the must obtain approval from the Office of The Gonococcal Isolate Surveillance
general public and other Federal Management and Budget (OMB) for each Project (GISP) was created in 1986 to
agencies the opportunity to comment on collection of information they conduct monitor trends in antimicrobial
a proposed and/or continuing or sponsor. In addition, the PRA also susceptibilities of N. gonorrhoeae
information collection, as required by requires Federal agencies to provide a strains in the United States. Data from
the Paperwork Reduction Act of 1995. 60-day notice in the Federal Register GISP are used to establish a scientific
This notice invites comment on a concerning each proposed collection of basis for the selection of gonococcal
proposed information collection project information, including each new therapies and to allow pro-active
titled ‘‘Gonococcal Isolate Surveillance proposed collection, each proposed changes to treatment guidelines before
Project (GISP)’’. The purpose of GISP is extension of existing collection of widespread resistance and failures of
to monitor trends in antimicrobial information, and each reinstatement of treatment occur. To increase capacity to
resistance in N. gonorrhoeae strains in previously approved information detect and monitor resistant gonorrhea
the United States in order to establish a collection before submitting the and improve the specificity of GISP, this
scientific basis for the selection of collection to the OMB for approval. To submission is a revision to include
gonococcal therapies and to allow comply with this requirement, we are collection of additional isolates and data
proactive changes to treatment
sradovich on DSK3GMQ082PROD with NOTICES
publishing this notice of a proposed elements.
guidelines before widespread resistance data collection as described below. The Centers for Disease Control and
and failures of treatment occur. The OMB is particularly interested in Prevention has designated N.
DATES: CDC must receive written comments that will help: gonorrhoeae as one of three ‘‘urgent’’
comments on or before April 6, 2018. 1. Evaluate whether the proposed antibiotic resistance threats in the
ADDRESSES: You may submit comments, collection of information is necessary United States. The CDC is requesting a
identified by Docket No. CDC–2018– for the proper performance of the three-year OMB approval for this
0019 by any of the following methods: functions of the agency, including revision, which directly responds to the
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![Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices 5103
National Strategy for Combating through GISP. Additionally, data from support the National Strategy for
Antibiotic Resistant Bacteria by GISP will also allow CDC to monitor Combating Antibiotic Resistant Bacteria.
improving and strengthening and evaluate the effectiveness of public There are no costs to respondents other
surveillance of antimicrobial resistance health interventions conducted to than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Sentinel site conducting core surveil- Demographic/Clinical Data ............... 20 240 11/60 880
lance.
Sentinel site conducting enhanced Demographic/Clinical Data ............... 10 840 12/60 1,680
surveillance.
Regional laboratory ........................... Antimicrobial Susceptibility Testing 4 3,300 40/60 8,800
Results.
Regional laboratory ........................... Control Strain Susceptibility Testing 4 48 5/60 16
Total ........................................... ........................................................... ........................ ........................ ........................ 11,376
Leroy A. Richardson, functions of the agency, including Background and Brief Description
Chief, Information Collection Review Office, whether the information will have
Office of Scientific Integrity, Office of the practical utility; This project seeks a three-year
Associate Director for Science, Office of the (b) Evaluate the accuracy of the extension to continue the passive
Director, Centers for Disease Control and agencies estimate of the burden of the reporting system for severe adverse
Prevention.
proposed collection of information, events (SAEs) associated with therapy
[FR Doc. 2018–02222 Filed 2–2–18; 8:45 am] including the validity of the for Latent Tuberculosis Infection (LTBI).
BILLING CODE 4163–18–P methodology and assumptions used; The system will rely on medical chart
(c) Enhance the quality, utility, and review and/or onsite investigations by
clarity of the information to be TB control staff. In 2004, CDC began
DEPARTMENT OF HEALTH AND collected; collecting reports of SAEs associated
HUMAN SERVICES with any treatment regimen for LTBI.
(d) Minimize the burden of the
For surveillance purposes, an SAE was
Centers for Disease Control and collection of information on those who
defined as any drug-associated reaction
Prevention are to respond, including, through the
resulting in a patient’s hospitalization or
use of appropriate automated,
[30Day–18–0773] death after at least one treatment dose
electronic, mechanical, or other
for LTBI. Reports of SAEs related to
technological collection techniques or
Agency Forms Undergoing Paperwork rifampicin plus pyrazinamide (RZ) and
other forms of information technology,
Reduction Act Review isoniazid (INH) INH have prompted a
e.g., permitting electronic submission of
need for this project a national
In accordance with the Paperwork responses; and
surveillance system of such events.
Reduction Act of 1995, the Centers for (e) Assess information collection
Disease Control and Prevention (CDC) costs. The objective of the project is to
has submitted the information To request additional information on determine the annual number and
collection request titled National the proposed project or to obtain a copy temporal trends of SAEs associated with
Surveillance for Severe Adverse Events of the information collection plan and any treatment for LTBI in the United
Among Persons on Treatment of Latent instruments, call (404) 639–7570 or States. Surveillance of such events will
Tuberculosis Infection to the Office of send an email to omb@cdc.gov. Direct provide data to support periodic
Management and Budget (OMB) for written comments and/or suggestions evaluation or potential revision of
review and approval. CDC previously regarding the items contained in this guidelines for treatment of persons with
published a ‘‘Proposed Data Collection notice to the Attention: CDC Desk LTBI.
Submitted for Public Comment and Officer, Office of Management and Potential respondents are any of the
Recommendations’’ notice on August Budget, 725 17th Street NW, 60 reporting areas for the national TB
22, 2017 to obtain comments from the Washington, DC 20503 or by fax to (202) surveillance system (the 50 states, the
public and affected agencies. CDC 395–5806. Provide written comments District of Columbia, New York City,
received one substantive comments within 30 days of notice publication. Puerto Rico, and 7 jurisdictions in the
related to the previous notice. This Pacific and Caribbean). Data will be
Proposed Project collected using the data collection form
notice serves to allow an additional 30
days for public and affected agency National Surveillance for Severe for SAEs associated with LTBI
comments. Adverse Events Associated with treatment. The data collection form is
Treatment of Latent Tuberculosis completed by healthcare providers and
sradovich on DSK3GMQ082PROD with NOTICES
CDC will accept all comments for this
proposed information collection project. Infection—(0920–0773, expiration health departments for each reported
The Office of Management and Budget 01/31/2018)—Extension—Division of hospitalization or death related to
is particularly interested in comments Tuberculosis Elimination (DTBE), treatment of LTBI and contains
that: National Center for HIV, Viral Hepatitis, demographic, clinical, and laboratory
(a) Evaluate whether the proposed STD, and TB Prevention NCHHSTP), information. Reporting of SAEs will be
collection of information is necessary Centers for Disease Control and conducted through telephone, email, or
for the proper performance of the Prevention (CDC). during CDC site visits.
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Document Created: 2018-02-03 01:25:09
Document Modified: 2018-02-03 01:25:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before April 6, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, 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] | |
| FR Citation | 83 FR 5102 |
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