80_FR_52456 80 FR 52289 - Proposed Data Collections Submitted for Public Comment and Recommendations [email protected]"> [email protected]" /> [email protected]" />

80 FR 52289 - Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 167 (August 28, 2015)

Page Range52289-52291
FR Document2015-21345

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the information collection entitled The Gonococcal Isolate Surveillance Project (GISP), which is the only source in the United States of national, regional, and site-specific gonococcal antibiotic resistance information that provides information to support informed and scientifically-based treatment recommendations. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [email protected]

Federal Register, Volume 80 Issue 167 (Friday, August 28, 2015)
[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52289-52291]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21345]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0307; Docket No. CDC-2015-0072]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

AGENCY: The Centers for Disease Control and Prevention (CDC).

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 to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
extension of the information collection entitled The Gonococcal Isolate 
Surveillance Project (GISP), which is the only source in the United 
States of national, regional, and site-specific gonococcal antibiotic 
resistance information that provides information to support informed 
and scientifically-based treatment recommendations.
    To request more information on the below proposed project or to 
obtain a copy of the information collection plan and instruments, call 
404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton 
Road, MS-D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

DATES: Written comments must be received on or before October 27, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0072 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    The Gonococcal Isolate Surveillance Project (GISP), (OMB No.0920-
0307 exp. 08/31/2016)--Extension--National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP),

[[Page 52290]]

Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The objectives of GISP are: (1) To monitor trends in antibiotic 
resistance of Neisseria gonorrhoeae strains in the United States and 
(2) to characterize resistant specimens. Surveillance of N. gonorrhoeae 
antibiotic resistance is important because: (1) Nearly all gonococcal 
infections are treated empirically (meaning that healthcare providers 
have to decide how to treat their patients without having resistance 
testing results for individual patients upon which to base clinical 
decision-making) and susceptibility/resistance testing data are not 
routinely available in clinical practice; (2) N. gonorrhoeae has 
consistently demonstrated the ability to develop resistance to the 
antibiotics used for treatment; (3) effective treatment of gonorrhea is 
a critical component of gonorrhea control and prevention, and (4) 
untreated or inadequately treated gonorrhea can cause serious 
reproductive health complications.
    GISP is the only source in the United States of national, regional, 
and site-specific gonococcal antibiotic resistance information. GISP 
provides information to support informed and scientifically-based 
treatment recommendations.
    GISP was established in 1986 as a voluntary surveillance project 
and now involves 5 regional laboratories and 30 publicly funded 
sexually transmitted disease (STD) clinics around the country. The STD 
clinics submit up to 25 gonococcal specimens (or isolates) per month to 
the regional laboratories, which measure the ability of the specimens 
to resist the effects of multiple antibiotics. Limited demographic and 
clinical information corresponding to the isolates (and that do not 
allow identification of the patient) are submitted directly by the 
clinics to CDC.
    During 1986-2015, GISP has demonstrated the ability to effectively 
achieve its objectives. The emergence of resistance in the United 
States to penicillin, tetracyclines, and fluoroquinolones among N. 
gonorrhoeae isolates was identified through GISP. Increased prevalence 
of fluoroquinolone-resistant N. gonorrhoeae (QRNG), as documented by 
GISP data, prompted CDC to update treatment recommendations for 
gonorrhea in CDC's Sexually Transmitted Diseases Treatment Guidelines, 
2006 and to release an MMWR article stating that CDC no longer 
recommended fluoroquinolones for treatment of gonococcal infections. 
Information from GISP thus allowed public health officials to change 
treatment recommendations before resistance became widespread, ensuring 
that patients were able to be successfully treated. Recently, GISP 
isolates demonstrated increasing minimum inhibitory concentrations of 
cefixime, which can be an early warning of impending resistance. This 
worrisome trend prompted CDC to again update treatment recommendations 
and no longer recommend the use of cefixime as first-line treatment for 
gonococcal infections.
    Under the GISP protocol, each of the 30 clinics submit an average 
of 20 isolates per clinic per month (i.e. 240 times per year) recorded 
on Form 1: Demographic/Clinical Data. The estimated time for clinical 
personnel to abstract data for Form 1: Demographic/Clinical Data is 11 
minutes per response.
    Each of the five Regional laboratories receives and processes an 
approximately 20 isolates from each referring clinic per month (i.e. 
121 isolates per regional laboratory per month [based on 2011 specimen 
volume]) using Form 2: Antimicrobial Susceptibility Testing. For Form 
2: Antimicrobial Susceptibility Testing, the annual frequency of 
responses per respondent is 1,452 (121 isolates x 12 months). Based on 
previous laboratory experience, the estimated burden of completing Form 
2 for each participating laboratory is 1 hour per response, which 
includes the time required for laboratory processing of the patient's 
isolate, gathering and maintaining the data needed, and completing and 
reviewing the collection of information. For Form 3: Control Strain 
Susceptibility Testing, a ``response'' is defined as the processing and 
recording of Regional laboratory data for a set of seven control 
strains. It takes approximately 12 minutes to process and record the 
Regional laboratory data on Form 3 for one set of seven control 
strains, of which there are 4 sets. The number of responses per 
respondent is 48 (4 sets x 12 months).
    The total estimated annual burden hours are 8,628. Respondents 
receive federal funds to participate in this project. There are no 
additional costs to respondents other than their time.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden   Total annual
      Type of respondents           Form name        Number of     responses per   per response     burden (in
                                                    respondents     respondent      (in hours)        hours)
----------------------------------------------------------------------------------------------------------------
Clinic........................  Demographic                   30             240           11/60           1,320
                                 Clinical Data
                                 Form 1.
Laboratory....................  Antimicrobial                  5           1,452               1           7,260
                                 Susceptibility
                                 Testing Form 2.
                                Control Strain                 5              48           12/60              48
                                 Susceptibility
                                 Testing Form 3.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           8,628
----------------------------------------------------------------------------------------------------------------


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. 2015-21345 Filed 8-27-15; 8:45 am]
 BILLING CODE 4163-18-P



                                                                                   Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices                                                                                                  52289

                                                                                                                      ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                 Average
                                                                                                                                                                                                   Number of
                                                                                                                                                                        Number of                                              burden per              Total burden
                                                     Type of respondents                                                Form name                                                                responses per
                                                                                                                                                                       respondents                                              response                 (in hrs.)
                                                                                                                                                                                                   respondent                    (in hrs.)

                                             Households ................................         Paper-based questionnaire .....................                                    1,215                             1                  12/60                  243
                                             Households ................................         Web-based questionnaire .......................                                      810                             1                  12/60                  162
                                             Utility employees ........................          Household listing .....................................                                6                             5                      3                   90
                                             Utility employees ........................          Water sample collection (grab samples)                                                 6                             3                 130/60                   39
                                             Utility employees ........................          Water sample collection (ultrafiltration                                               6                             2                  30/60                    6
                                                                                                   samples).
                                             Utility employees ........................          Low pressure event form ........................                                           6                         5                   15/60                   8

                                                  Total ....................................      .................................................................   ........................   ........................   ........................            548



                                             Leroy A. Richardson,                                                      GA 30333 or send an email to omb@                                             information, and each reinstatement of
                                             Chief, Information Collection Review Office,                              cdc.gov.                                                                      previously approved information
                                             Office of Scientific Integrity, Office of the                                                                                                           collection before submitting the
                                                                                                                       DATES: Written comments must be
                                             Associate Director for Science, Office of the                                                                                                           collection to OMB for approval. To
                                             Director, Centers for Disease Control and                                 received on or before October 27, 2015.
                                                                                                                       ADDRESSES: You may submit comments,
                                                                                                                                                                                                     comply with this requirement, we are
                                             Prevention.
                                                                                                                       identified by Docket No. CDC–2015–                                            publishing this notice of a proposed
                                             [FR Doc. 2015–21346 Filed 8–27–15; 8:45 am]                                                                                                             data collection as described below.
                                             BILLING CODE 4163–18–P
                                                                                                                       0072 by any of the following methods:
                                                                                                                         • Federal eRulemaking Portal:                                                  Comments are invited on: (a) Whether
                                                                                                                       Regulation.gov. Follow the instructions                                       the proposed collection of information
                                             DEPARTMENT OF HEALTH AND                                                  for submitting comments.                                                      is necessary for the proper performance
                                             HUMAN SERVICES                                                              • Mail: Leroy A. Richardson,                                                of the functions of the agency, including
                                                                                                                       Information Collection Review Office,                                         whether the information shall have
                                             Centers for Disease Control and                                           Centers for Disease Control and                                               practical utility; (b) the accuracy of the
                                             Prevention                                                                Prevention, 1600 Clifton Road NE., MS–                                        agency’s estimate of the burden of the
                                                                                                                       D74, Atlanta, Georgia 30329.                                                  proposed collection of information; (c)
                                             [60Day–15–0307; Docket No. CDC–2015–                                        Instructions: All submissions received
                                             0072]                                                                                                                                                   ways to enhance the quality, utility, and
                                                                                                                       must include the agency name and                                              clarity of the information to be
                                             Proposed Data Collections Submitted                                       Docket Number. All relevant comments                                          collected; (d) ways to minimize the
                                             for Public Comment and                                                    received will be posted without change                                        burden of the collection of information
                                             Recommendations                                                           to Regulations.gov, including any                                             on respondents, including through the
                                                                                                                       personal information provided. For                                            use of automated collection techniques
                                             AGENCY: The Centers for Disease Control                                   access to the docket to read background                                       or other forms of information
                                             and Prevention (CDC).                                                     documents or comments received, go to                                         technology; and (e) estimates of capital
                                             ACTION: Notice with comment period.                                       Regulations.gov.                                                              or start-up costs and costs of operation,
                                             SUMMARY:   The Centers for Disease                                          Please note: All public comment should be                                   maintenance, and purchase of services
                                                                                                                       submitted through the Federal eRulemaking                                     to provide information. Burden means
                                             Control and Prevention (CDC), as part of                                  portal (Regulations.gov) or by U.S. mail to the
                                             its continuing effort to reduce public                                                                                                                  the total time, effort, or financial
                                                                                                                       address listed above.                                                         resources expended by persons to
                                             burden and maximize the utility of
                                             government information, invites the                                       FOR FURTHER INFORMATION CONTACT:    To                                        generate, maintain, retain, disclose or
                                             general public and other Federal                                          request more information on the                                               provide information to or for a Federal
                                             agencies to take this opportunity to                                      proposed project or to obtain a copy of                                       agency. This includes the time needed
                                             comment on proposed and/or                                                the information collection plan and                                           to review instructions; to develop,
                                             continuing information collections, as                                    instruments, contact the Information                                          acquire, install and utilize technology
                                             required by the Paperwork Reduction                                       Collection Review Office, Centers for                                         and systems for the purpose of
                                             Act of 1995. This notice invites                                          Disease Control and Prevention, 1600                                          collecting, validating and verifying
                                             comment on the proposed extension of                                      Clifton Road NE., MS–D74, Atlanta,                                            information, processing and
                                             the information collection entitled The                                   Georgia 30329; phone: 404–639–7570;                                           maintaining information, and disclosing
                                             Gonococcal Isolate Surveillance Project                                   Email: omb@cdc.gov.                                                           and providing information; to train
                                             (GISP), which is the only source in the                                   SUPPLEMENTARY INFORMATION: Under the                                          personnel and to be able to respond to
                                             United States of national, regional, and                                  Paperwork Reduction Act of 1995 (PRA)                                         a collection of information, to search
                                             site-specific gonococcal antibiotic                                       (44 U.S.C. 3501–3520), Federal agencies                                       data sources, to complete and review
                                             resistance information that provides                                      must obtain approval from the Office of                                       the collection of information; and to
                                             information to support informed and                                       Management and Budget (OMB) for each                                          transmit or otherwise disclose the
                                             scientifically-based treatment                                            collection of information they conduct                                        information.
Lhorne on DSK5TPTVN1PROD with NOTICES




                                             recommendations.                                                          or sponsor. In addition, the PRA also                                         Proposed Project
                                                To request more information on the                                     requires Federal agencies to provide a
                                             below proposed project or to obtain a                                     60-day notice in the Federal Register                                           The Gonococcal Isolate Surveillance
                                             copy of the information collection plan                                   concerning each proposed collection of                                        Project (GISP), (OMB No.0920–0307
                                             and instruments, call 404–639–7570 or                                     information, including each new                                               exp. 08/31/2016)—Extension—National
                                             send comments to Leroy A. Richardson,                                     proposed collection, each proposed                                            Center for HIV/AIDS, Viral Hepatitis,
                                             1600 Clifton Road, MS–D74, Atlanta,                                       extension of existing collection of                                           STD, and TB Prevention (NCHHSTP),


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                                             52290                                    Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices

                                             Centers for Disease Control and                                           which measure the ability of the                                              isolates per clinic per month (i.e. 240
                                             Prevention (CDC).                                                         specimens to resist the effects of                                            times per year) recorded on Form 1:
                                                                                                                       multiple antibiotics. Limited                                                 Demographic/Clinical Data. The
                                             Background and Brief Description
                                                                                                                       demographic and clinical information                                          estimated time for clinical personnel to
                                                The objectives of GISP are: (1) To                                     corresponding to the isolates (and that                                       abstract data for Form 1: Demographic/
                                             monitor trends in antibiotic resistance                                   do not allow identification of the                                            Clinical Data is 11 minutes per
                                             of Neisseria gonorrhoeae strains in the                                   patient) are submitted directly by the                                        response.
                                             United States and (2) to characterize                                     clinics to CDC.                                                                  Each of the five Regional laboratories
                                             resistant specimens. Surveillance of N.                                      During 1986–2015, GISP has                                                 receives and processes an
                                             gonorrhoeae antibiotic resistance is                                      demonstrated the ability to effectively                                       approximately 20 isolates from each
                                             important because: (1) Nearly all                                         achieve its objectives. The emergence of                                      referring clinic per month (i.e. 121
                                             gonococcal infections are treated                                         resistance in the United States to                                            isolates per regional laboratory per
                                             empirically (meaning that healthcare                                      penicillin, tetracyclines, and                                                month [based on 2011 specimen
                                             providers have to decide how to treat                                     fluoroquinolones among N. gonorrhoeae                                         volume]) using Form 2: Antimicrobial
                                             their patients without having resistance                                  isolates was identified through GISP.                                         Susceptibility Testing. For Form 2:
                                             testing results for individual patients                                   Increased prevalence of                                                       Antimicrobial Susceptibility Testing,
                                             upon which to base clinical decision-                                     fluoroquinolone-resistant N.                                                  the annual frequency of responses per
                                             making) and susceptibility/resistance                                     gonorrhoeae (QRNG), as documented by                                          respondent is 1,452 (121 isolates × 12
                                             testing data are not routinely available                                  GISP data, prompted CDC to update                                             months). Based on previous laboratory
                                             in clinical practice; (2) N. gonorrhoeae                                  treatment recommendations for                                                 experience, the estimated burden of
                                             has consistently demonstrated the                                         gonorrhea in CDC’s Sexually                                                   completing Form 2 for each
                                             ability to develop resistance to the                                      Transmitted Diseases Treatment                                                participating laboratory is 1 hour per
                                             antibiotics used for treatment; (3)                                       Guidelines, 2006 and to release an                                            response, which includes the time
                                             effective treatment of gonorrhea is a                                     MMWR article stating that CDC no                                              required for laboratory processing of the
                                             critical component of gonorrhea control                                   longer recommended fluoroquinolones                                           patient’s isolate, gathering and
                                             and prevention, and (4) untreated or                                      for treatment of gonococcal infections.                                       maintaining the data needed, and
                                             inadequately treated gonorrhea can                                        Information from GISP thus allowed                                            completing and reviewing the collection
                                             cause serious reproductive health                                         public health officials to change                                             of information. For Form 3: Control
                                             complications.                                                            treatment recommendations before                                              Strain Susceptibility Testing, a
                                                GISP is the only source in the United                                  resistance became widespread, ensuring                                        ‘‘response’’ is defined as the processing
                                             States of national, regional, and site-                                   that patients were able to be                                                 and recording of Regional laboratory
                                             specific gonococcal antibiotic resistance                                 successfully treated. Recently, GISP                                          data for a set of seven control strains. It
                                             information. GISP provides information                                    isolates demonstrated increasing                                              takes approximately 12 minutes to
                                             to support informed and scientifically-                                   minimum inhibitory concentrations of                                          process and record the Regional
                                             based treatment recommendations.                                          cefixime, which can be an early warning                                       laboratory data on Form 3 for one set of
                                                GISP was established in 1986 as a                                      of impending resistance. This                                                 seven control strains, of which there are
                                             voluntary surveillance project and now                                    worrisome trend prompted CDC to again                                         4 sets. The number of responses per
                                             involves 5 regional laboratories and 30                                   update treatment recommendations and                                          respondent is 48 (4 sets × 12 months).
                                             publicly funded sexually transmitted                                      no longer recommend the use of                                                   The total estimated annual burden
                                             disease (STD) clinics around the                                          cefixime as first-line treatment for                                          hours are 8,628. Respondents receive
                                             country. The STD clinics submit up to                                     gonococcal infections.                                                        federal funds to participate in this
                                             25 gonococcal specimens (or isolates)                                        Under the GISP protocol, each of the                                       project. There are no additional costs to
                                             per month to the regional laboratories,                                   30 clinics submit an average of 20                                            respondents other than their time.

                                                                                                                    ESTIMATE OF ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                 Average
                                                                                                                                                                                                   Number of                                           Total annual
                                                                                                                                                                        Number of                                              burden per
                                                         Type of respondents                                                Form name                                                            responses per                                            burden
                                                                                                                                                                       respondents                                              response
                                                                                                                                                                                                   respondent                                           (in hours)
                                                                                                                                                                                                                                (in hours)

                                             Clinic .................................................   Demographic Clinical Data Form 1 ..                                               30                     240                       11/60              1,320
                                             Laboratory .........................................       Antimicrobial Susceptibility Testing                                               5                   1,452                           1              7,260
                                                                                                          Form 2.
                                                                                                        Control Strain Susceptibility Testing                                               5                        48                   12/60                  48
                                                                                                          Form 3.

                                                   Total ...........................................    ...........................................................   ........................   ........................   ........................          8,628



                                             Leroy A. Richardson,
                                             Chief, Information Collection Review Office,
Lhorne on DSK5TPTVN1PROD with NOTICES




                                             Office of Scientific Integrity, Office of the
                                             Associate Director for Science, Office of the
                                             Director, Centers for Disease Control and
                                             Prevention.
                                             [FR Doc. 2015–21345 Filed 8–27–15; 8:45 am]
                                             BILLING CODE 4163–18–P




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                                                                           Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices                                           52291

                                             DEPARTMENT OF HEALTH AND                                Clifton Road NE., MS–D74, Atlanta,                    (CLAS) Survey—New—National Center
                                             HUMAN SERVICES                                          Georgia 30329; phone: 404–639–7570.                   for Health Statistics (NCHS), Centers for
                                                                                                     SUPPLEMENTARY INFORMATION: Under the                  Disease Control and Prevention (CDC).
                                             Centers for Disease Control and                         Paperwork Reduction Act of 1995 (PRA)
                                             Prevention                                                                                                    Background and Brief Description
                                                                                                     (44 U.S.C. 3501–3520), Federal agencies
                                                                                                     must obtain approval from the Office of                  As the population of the United States
                                             [60Day–15–15BCU; Docket No. CDC–2015–
                                             0074]                                                   Management and Budget (OMB) for each                  becomes increasingly diverse, it is
                                                                                                     collection of information they conduct                important that health care providers
                                             Proposed Data Collections Submitted                     or sponsor. In addition, the PRA also                 deliver culturally and linguistically
                                             for Public Comment and                                  requires Federal agencies to provide a                competent services. Culturally and
                                             Recommendations                                         60-day notice in the Federal Register                 linguistically appropriate services
                                                                                                     concerning each proposed collection of                (CLAS) are respectful of and responsive
                                             AGENCY: Centers for Disease Control and                                                                       to individual cultural health beliefs and
                                                                                                     information, including each new
                                             Prevention (CDC), Department of Health                                                                        practices, preferred languages, health
                                                                                                     proposed collection, each proposed
                                             and Human Services (HHS).                                                                                     literacy levels, and communication
                                                                                                     extension of existing collection of
                                             ACTION: Notice with comment period.                     information, and each reinstatement of                needs. The National CLAS Standards in
                                                                                                     previously approved information                       Health and Health Care were established
                                             SUMMARY:    The Centers for Disease                                                                           in 2000 by the Office of Minority Health
                                                                                                     collection before submitting the
                                             Control and Prevention (CDC), as part of                                                                      (OMH), Department of Health and
                                                                                                     collection to OMB for approval. To
                                             its continuing effort to reduce public                                                                        Human Services (DHHS) to advance
                                                                                                     comply with this requirement, we are
                                             burden and maximize the utility of                                                                            health equity, improve quality, and
                                                                                                     publishing this notice of a proposed
                                             government information, invites the                                                                           eliminate health care disparities. In
                                                                                                     data collection as described below.
                                             general public and other Federal                                                                              2013, OMH published the Enhanced
                                             agencies to take this opportunity to                       Comments are invited on: (a) Whether
                                                                                                     the proposed collection of information                Standards for CLAS in Health and
                                             comment on proposed and/or                                                                                    Health Care to revise the National CLAS
                                             continuing information collections, as                  is necessary for the proper performance
                                                                                                     of the functions of the agency, including             Standards in order to reflect
                                             required by the Paperwork Reduction                                                                           advancements made since 2000, expand
                                             Act of 1995. This notice invites                        whether the information shall have
                                                                                                     practical utility; (b) the accuracy of the            their scope and improve their clarity to
                                             comment on the National Ambulatory                                                                            ensure better understanding and
                                             Medical Care Survey (NAMCS) on                          agency’s estimate of the burden of the
                                                                                                     proposed collection of information; (c)               implementation. Although there has
                                             Culturally and Linguistically                                                                                 been increased awareness and efforts to
                                             Appropriate Services (CLAS) Survey.                     ways to enhance the quality, utility, and
                                                                                                     clarity of the information to be                      train culturally and linguistically
                                             The purpose of the NAMCS CLAS                                                                                 competent health care providers, there
                                             survey is to describe the awareness,                    collected; (d) ways to minimize the
                                                                                                     burden of the collection of information               has not been a systematic evaluation of
                                             training, adoption, and implementation                                                                        the level of adoption or implementation
                                             of the Enhanced Standards for CLAS in                   on respondents, including through the
                                                                                                     use of automated collection techniques                of the National CLAS Standards among
                                             Health and Health Care among office-                                                                          physicians. Due to the limited
                                             based physicians.                                       or other forms of information
                                                                                                     technology; and (e) estimates of capital              understanding of how the Standards are
                                             DATES: Written comments must be                                                                               adopted and implemented, it is difficult
                                                                                                     or start-up costs and costs of operation,
                                             received on or before October 27, 2015.                 maintenance, and purchase of services                 to know what goals have been achieved
                                             ADDRESSES: You may submit comments,                     to provide information. Burden means                  and which need more work.
                                             identified by Docket No. CDC–2015–                      the total time, effort, or financial                     OMH came to NCHS’ Division of
                                             0074 by any of the following methods:                   resources expended by persons to                      Health Care Statistics with this project
                                                • Federal eRulemaking Portal:                        generate, maintain, retain, disclose or               because of our expertise collecting data
                                             Regulations.gov. Follow the instructions                provide information to or for a Federal               from physicians in the NAMCS. The
                                             for submitting comments.                                agency. This includes the time needed                 NAMCS CLAS project meets two of the
                                                • Mail: Leroy A. Richardson,                         to review instructions; to develop,                   Division’s missions: Conduct
                                             Information Collection Review Office,                   acquire, install and utilize technology               multidisciplinary research directed
                                             Centers for Disease Control and                         and systems for the purpose of                        towards development of new scientific
                                             Prevention, 1600 Clifton Road NE., MS–                  collecting, validating and verifying                  knowledge on the provision, use,
                                             D74, Atlanta, Georgia 30329.                            information, processing and                           quality, and appropriateness of
                                                Instructions: All submissions received               maintaining information, and disclosing               ambulatory care; and develop and
                                             must include the agency name and                        and providing information; to train                   sustain collaborative partnerships
                                             Docket Number. All relevant comments                    personnel and to be able to respond to                internally within DHHS and externally
                                             received will be posted without change                  a collection of information, to search                with public, private, domestic and
                                             to Regulations.gov, including any                       data sources, to complete and review                  international entities on health care
                                             personal information provided. For                      the collection of information; and to                 statistics programs. The purpose of the
                                             access to the docket to read background                 transmit or otherwise disclose the                    NAMCS CLAS survey is to describe the
                                             documents or comments received, go to                   information.                                          awareness, training, adoption, and
                                             Regulations.gov.                                                                                              implementation of the Enhanced
Lhorne on DSK5TPTVN1PROD with NOTICES




                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                     Proposed Project                                      Standards for CLAS in Health and
                                             Leroy A. Richardson, Information                          National Ambulatory Medical Care                    Health Care among office-based
                                             Collection Review Office, Centers for                   Survey (NAMCS) on Culturally and                      physicians. The information will be
                                             Disease Control and Prevention,1600                     Linguistically Appropriate Services                   collected directly from physician




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Document Created: 2015-12-15 11:04:42
Document Modified: 2015-12-15 11:04:42
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.
DatesWritten comments must be received on or before October 27, 2015.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 Citation80 FR 52289 

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