83_FR_44043 83 FR 43876 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 43876 - 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 167 (August 28, 2018)

Page Range43876-43877
FR Document2018-18589

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 CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for revision to the previously approved project used to monitor and evaluate performances and practices among national laboratories M. tuberculosis susceptibility testing.

Federal Register, Volume 83 Issue 167 (Tuesday, August 28, 2018) 
[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Notices]
[Pages 43876-43877]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0600; Docket No. CDC-CDC-2008-0079]


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 CDC Model Performance Evaluation 
Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing 
information collection. CDC is requesting a three-year approval for 
revision to the previously approved project used to monitor and 
evaluate performances and practices among national laboratories M. 
tuberculosis susceptibility testing.

DATES: CDC must receive written comments on or before October 29, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2008-
00791 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 Jeffery 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

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis Susceptibility testing (OMB #0920-0600, expiration 3/31/
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 CDC is requesting a revision to the approved information 
collection, CDC Model Performance for Mycobacterium tuberculosis Drug 
Susceptibility Testing (OMB Control Number 0920-0600). Clearance is 
requested for a period of three years. Revision of this information 
collection will not require changes in the scope of the study. This 
revision includes (a) modification of the Participant Biosafety 
Compliance Letter of Agreement; (b) modification of the Instructions to 
Participants Letter; (c) modification of the MPEP Mycobacterium Results 
Worksheet; (d) Request for approval of a MPEP Mycobacterium 
tuberculosis Minimum Inhibitory Concentration (MIC) Results Form for 
laboratories that perform Sensititre Drug Susceptibility Testing (DST) 
to record MIC results; and (e) reduction in request for burden hours.
    While the overall number of cases of TB in the U.S. has decreased, 
rates still remain high among foreign-born persons, prisoners, homeless 
populations, and individuals infected with HIV in major metropolitan 
areas. To reach the goal of eliminating TB, the Model Performance 
Evaluation Program for Mycobacterium tuberculosis Susceptibility 
Testing is used to monitor and evaluate performance and practices among 
national laboratories performing M. tuberculosis susceptibility 
testing. Participation in this program is one way

[[Page 43877]]

laboratories can ensure high-quality laboratory testing, resulting in 
accurate and reliable testing results.
    By providing an evaluation program to assess the ability of the 
laboratories to test for drug resistant M. tuberculosis strains, 
laboratories also have a self-assessment tool to aid in optimizing 
their skills in susceptibility testing. The information obtained from 
the laboratories on susceptibility practices and procedures is used to 
establish variables related to good performance, assessing training 
needs, and aid with the development of practice standards.
    Participants in this program include domestic clinical and public 
health laboratories. Data collection from laboratory participants 
occurs twice per year. The data collected in this program will include 
the susceptibility test results of primary and secondary drugs, drug 
concentrations, and test methods performed by laboratories on a set of 
performance evaluation (PE) samples. The PE samples are sent to 
participants twice a year. Participants also report demographic data 
such as laboratory type and the number of tests performed annually. The 
total estimated annual burden hours are 129. There is no cost to 
respondents to participate 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
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory...........  Participant                   80               1            5/60               7
                                 Biosafety
                                 Compliance
                                 Letter of
                                 Agreement.
                                MPEP                          80               2           30/60              80
                                 Mycobacterium
                                 tuberculosis
                                 Results
                                 Worksheet.
                                Online Survey                 80               2           15/60              40
                                 Instrument.
                                MPEP                           4               2           15/60               2
                                 Mycobacterium
                                 tuberculosis
                                 Minimum
                                 Inhibitory
                                 Concentration
                                 Results Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             129
----------------------------------------------------------------------------------------------------------------


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. 2018-18589 Filed 8-27-18; 8:45 am]
BILLING CODE 4163-18-P

43876 Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Type of respondents Form name responses per respondents response respondent (in hours) International panel physicians ........................ TB Indicators Excel Spreadsheet .................. 336 1 3 Jeffrey M. Zirger, Disease Control and Prevention, 1600 4. Minimize the burden of the Acting Chief, Information Collection Review Clifton Road NE, MS–D74, Atlanta, collection of information on those who Office, Office of Scientific Integrity, Office Georgia 30329. are to respond, including through the of the Associate Director for Science, Office Instructions: All submissions received use of appropriate automated, of the Director, Centers for Disease Control electronic, mechanical, or other must include the agency name and and Prevention. Docket Number. CDC will post, without technological collection techniques or [FR Doc. 2018–18588 Filed 8–27–18; 8:45 am] change, all relevant comments to other forms of information technology, BILLING CODE 4163–18–P e.g., permitting electronic submissions Regulations.gov. Please note: Submit all comments of responses. through the Federal eRulemaking portal 5. Assess information collection costs. DEPARTMENT OF HEALTH AND HUMAN SERVICES (regulations.gov) or by U.S. mail to the Proposed Project address listed above. Centers for Disease Control and CDC Model Performance Evaluation FOR FURTHER INFORMATION CONTACT: To Prevention Program (MPEP) for Mycobacterium request more information on the tuberculosis Susceptibility testing (OMB [60Day–18–0600; Docket No. CDC–CDC– proposed project or to obtain a copy of #0920–0600, expiration 3/31/2019)— 2008–0079] the information collection plan and Revision—National Center for HIV/ instruments, contact Jeffery M. Zirger, AIDS, Viral Hepatitis, STD, and TB Proposed Data Collection Submitted Information Collection Review Office, Prevention (NCHHSTP), Centers for for Public Comment and Centers for Disease Control and Disease Control and Prevention (CDC). Recommendations Prevention, 1600 Clifton Road NE, MS– D74, Atlanta, Georgia 30329; phone: Background and Brief Description AGENCY: Centers for Disease Control and 404–639–7570; Email: omb@cdc.gov. The CDC is requesting a revision to Prevention (CDC), Department of Health and Human Services (HHS). SUPPLEMENTARY INFORMATION: Under the the approved information collection, ACTION: Notice with comment period. Paperwork Reduction Act of 1995 (PRA) CDC Model Performance for (44 U.S.C. 3501–3520), Federal agencies Mycobacterium tuberculosis Drug SUMMARY: The Centers for Disease must obtain approval from the Office of Susceptibility Testing (OMB Control Control and Prevention (CDC), as part of Management and Budget (OMB) for each Number 0920–0600). Clearance is its continuing effort to reduce public collection of information they conduct requested for a period of three years. burden and maximize the utility of or sponsor. In addition, the PRA also Revision of this information collection government information, invites the requires Federal agencies to provide a will not require changes in the scope of general public and other Federal 60-day notice in the Federal Register the study. This revision includes (a) agencies the opportunity to comment on concerning each proposed collection of modification of the Participant Biosafety a proposed and/or continuing information, including each new Compliance Letter of Agreement; (b) information collection, as required by proposed collection, each proposed modification of the Instructions to the Paperwork Reduction Act of 1995. extension of existing collection of Participants Letter; (c) modification of This notice invites comment on a information, and each reinstatement of the MPEP Mycobacterium Results proposed information collection project previously approved information Worksheet; (d) Request for approval of titled CDC Model Performance collection before submitting the a MPEP Mycobacterium tuberculosis Evaluation Program (MPEP) for collection to the OMB for approval. To Minimum Inhibitory Concentration Mycobacterium tuberculosis comply with this requirement, we are (MIC) Results Form for laboratories that Susceptibility Testing information publishing this notice of a proposed perform Sensititre Drug Susceptibility collection. CDC is requesting a three- data collection as described below. Testing (DST) to record MIC results; and year approval for revision to the The OMB is particularly interested in (e) reduction in request for burden previously approved project used to comments that will help: hours. monitor and evaluate performances and 1. Evaluate whether the proposed While the overall number of cases of practices among national laboratories M. collection of information is necessary TB in the U.S. has decreased, rates still tuberculosis susceptibility testing. for the proper performance of the remain high among foreign-born DATES: CDC must receive written functions of the agency, including persons, prisoners, homeless comments on or before October 29, whether the information will have populations, and individuals infected 2018. practical utility; with HIV in major metropolitan areas. ADDRESSES: You may submit comments, 2. Evaluate the accuracy of the To reach the goal of eliminating TB, the daltland on DSKBBV9HB2PROD with NOTICES identified by Docket No. CDC–2008– agency’s estimate of the burden of the Model Performance Evaluation Program 00791 by any of the following methods: proposed collection of information, for Mycobacterium tuberculosis • Federal eRulemaking Portal: including the validity of the Susceptibility Testing is used to monitor Regulations.gov. Follow the instructions methodology and assumptions used; and evaluate performance and practices for submitting comments. 3. Enhance the quality, utility, and among national laboratories performing • Mail: Jeffrey M. Zirger, Information clarity of the information to be M. tuberculosis susceptibility testing. Collection Review Office, Centers for collected; and Participation in this program is one way VerDate Sep<11>2014 20:00 Aug 27, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\28AUN1.SGM 28AUN1

Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Notices 43877 laboratories can ensure high-quality and procedures is used to establish drug concentrations, and test methods laboratory testing, resulting in accurate variables related to good performance, performed by laboratories on a set of and reliable testing results. assessing training needs, and aid with performance evaluation (PE) samples. By providing an evaluation program the development of practice standards. The PE samples are sent to participants to assess the ability of the laboratories Participants in this program include twice a year. Participants also report to test for drug resistant M. tuberculosis domestic clinical and public health demographic data such as laboratory strains, laboratories also have a self- laboratories. Data collection from type and the number of tests performed assessment tool to aid in optimizing laboratory participants occurs twice per annually. The total estimated annual their skills in susceptibility testing. The year. The data collected in this program burden hours are 129. There is no cost information obtained from the will include the susceptibility test to respondents to participate other than laboratories on susceptibility practices results of primary and secondary drugs, their time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Type of Number of burden per Total burden Form name responses per respondents respondents response (in hours) respondent (in hours) Domestic Laboratory ......................... Participant Biosafety Compliance 80 1 5/60 7 Letter of Agreement. MPEP Mycobacterium tuberculosis 80 2 30/60 80 Results Worksheet. Online Survey Instrument ................ 80 2 15/60 40 MPEP Mycobacterium tuberculosis 4 2 15/60 2 Minimum Inhibitory Concentration Results Form. Total ........................................... ........................................................... ........................ ........................ ........................ 129 Jeffrey M. Zirger, include on the list: Bumetanide, identifies you in the body of your Acting Chief, Information Collection Review nicardipine hydrochloride, and comments, that information will be Office, Office of Scientific Integrity, Office vasopressin. Additional bulk drug posted on https://www.regulations.gov. of the Associate Director for Science, Office substances nominated by the public for • If you want to submit a comment of the Director, Centers for Disease Control inclusion on this list are currently under and Prevention. with confidential information that you consideration and will be the subject of do not wish to be made available to the [FR Doc. 2018–18589 Filed 8–27–18; 8:45 am] future notices. public, submit the comment as a BILLING CODE 4163–18–P DATES: Submit either electronic or written/paper submission and in the written comments on the notice by manner detailed (see ‘‘Written/Paper October 29, 2018 to ensure that the Submissions’’ and ‘‘Instructions’’). DEPARTMENT OF HEALTH AND Agency considers your comment on this HUMAN SERVICES Written/Paper Submissions notice before it begins work on a notice Food and Drug Administration reflecting the Agency’s final decision Submit written/paper submissions as about whether to include these follows: [Docket No. FDA–2018–N–3240] substances on the 503B Bulks List. • Mail/Hand Delivery/Courier (for ADDRESSES: You may submit comments Written/Paper Submissions): Dockets List of Bulk Drug Substances for Which There is a Clinical Need Under at any time as follows: Management Staff (HFA–305), Food and Section 503B of the Federal Food, Electronic Submissions Drug Administration, 5630 Fishers Drug, and Cosmetic Act Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments in the AGENCY: Food and Drug Administration, following way: • For written/paper comments HHS. • Federal eRulemaking Portal: submitted to the Dockets Management https://www.regulations.gov. Follow the Staff, FDA will post your comment, as ACTION: Notice. instructions for submitting comments. well as any attachments, except for SUMMARY: The Food and Drug Comments submitted electronically, information submitted, marked and Administration (FDA or Agency) is including attachments, to https:// identified, as confidential, if submitted developing a list of bulk drug www.regulations.gov will be posted to as detailed in ‘‘Instructions.’’ substances (active pharmaceutical the docket unchanged. Because your Instructions: All submissions received ingredients) for which there is a clinical comment will be made public, you are must include the Docket No. FDA– need (the 503B Bulks List). Drug solely responsible for ensuring that your 2018–N–3240 for ‘‘List of Bulk Drug products that outsourcing facilities comment does not include any Substances For Which There Is a compound using bulk drug substances confidential information that you or a Clinical Need Under Section 503B of the daltland on DSKBBV9HB2PROD with NOTICES on the 503B Bulks List qualify for third party may not wish to be posted, Federal Food, Drug, and Cosmetic Act.’’ certain exemptions from the Federal such as medical information, your or Received comments will be placed in Food, Drug, and Cosmetic Act (FD&C anyone else’s Social Security number, or the docket and, except for those Act) provided certain conditions are confidential business information, such submitted as ‘‘Confidential met. This notice identifies three bulk as a manufacturing process. Please note Submissions,’’ publicly viewable at drug substances that FDA has that if you include your name, contact https://www.regulations.gov or at the considered and is proposing not to information, or other information that Dockets Management Staff between 9 VerDate Sep<11>2014 20:00 Aug 27, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\28AUN1.SGM 28AUN1


Document Created: 2018-08-28 00:23:26
Document Modified: 2018-08-28 00:23:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesCDC must receive written comments on or before October 29, 2018.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery 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]
FR Citation83 FR 43876 
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