Att 2 60d FRN

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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hrs.)

Total burden
(in hrs.)

Form name

Households ................................
Households ................................
Utility employees ........................
Utility employees ........................
Utility employees ........................

1,215
810
6
6
6

1
1
5
3
2

12/60
12/60
3
130/60
30/60

243
162
90
39
6

Utility employees ........................

Paper-based questionnaire .....................
Web-based questionnaire .......................
Household listing .....................................
Water sample collection (grab samples)
Water sample collection (ultrafiltration
samples).
Low pressure event form ........................

6

5

15/60

8

Total ....................................

.................................................................

........................

........................

........................

548

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. 2015–21346 Filed 8–27–15; 8:45 am]
BILLING CODE 4163–18–P

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
The Centers for Disease Control
and Prevention (CDC).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies 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,

SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondents

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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.

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: [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
FOR FURTHER INFORMATION CONTACT:

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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),

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52290

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

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 decisionmaking) 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 sitespecific gonococcal antibiotic resistance
information. GISP provides information
to support informed and scientificallybased 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,

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 × 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 × 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.

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

ESTIMATE OF ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total annual
burden
(in hours)

Form name

Clinic .................................................
Laboratory .........................................

Demographic Clinical Data Form 1 ..
Antimicrobial Susceptibility Testing
Form 2.
Control Strain Susceptibility Testing
Form 3.

30
5

240
1,452

11/60
1

1,320
7,260

5

48

12/60

48

...........................................................

........................

........................

........................

8,628

Total ...........................................

Lhorne on DSK5TPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Type of respondents

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

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16:41 Aug 27, 2015

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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15BCU; Docket No. CDC–2015–
0074]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies 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 National Ambulatory
Medical Care Survey (NAMCS) on
Culturally and Linguistically
Appropriate Services (CLAS) Survey.
The purpose of the NAMCS CLAS
survey is to describe the awareness,
training, adoption, and implementation
of the Enhanced Standards for CLAS in
Health and Health Care among officebased physicians.
DATES: Written comments must be
received on or before October 27, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0074 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. 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.
FOR FURTHER INFORMATION CONTACT:
Leroy A. Richardson, Information
Collection Review Office, Centers for
Disease Control and Prevention,1600

Lhorne on DSK5TPTVN1PROD with NOTICES

SUMMARY:

VerDate Sep<11>2014

16:41 Aug 27, 2015

Jkt 235001

Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570.
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
National Ambulatory Medical Care
Survey (NAMCS) on Culturally and
Linguistically Appropriate Services

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52291

(CLAS) Survey—New—National Center
for Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
As the population of the United States
becomes increasingly diverse, it is
important that health care providers
deliver culturally and linguistically
competent services. Culturally and
linguistically appropriate services
(CLAS) are respectful of and responsive
to individual cultural health beliefs and
practices, preferred languages, health
literacy levels, and communication
needs. The National CLAS Standards in
Health and Health Care were established
in 2000 by the Office of Minority Health
(OMH), Department of Health and
Human Services (DHHS) to advance
health equity, improve quality, and
eliminate health care disparities. In
2013, OMH published the Enhanced
Standards for CLAS in Health and
Health Care to revise the National CLAS
Standards in order to reflect
advancements made since 2000, expand
their scope and improve their clarity to
ensure better understanding and
implementation. Although there has
been increased awareness and efforts to
train culturally and linguistically
competent health care providers, there
has not been a systematic evaluation of
the level of adoption or implementation
of the National CLAS Standards among
physicians. Due to the limited
understanding of how the Standards are
adopted and implemented, it is difficult
to know what goals have been achieved
and which need more work.
OMH came to NCHS’ Division of
Health Care Statistics with this project
because of our expertise collecting data
from physicians in the NAMCS. The
NAMCS CLAS project meets two of the
Division’s missions: Conduct
multidisciplinary research directed
towards development of new scientific
knowledge on the provision, use,
quality, and appropriateness of
ambulatory care; and develop and
sustain collaborative partnerships
internally within DHHS and externally
with public, private, domestic and
international entities on health care
statistics programs. The purpose of the
NAMCS CLAS survey is to describe the
awareness, training, adoption, and
implementation of the Enhanced
Standards for CLAS in Health and
Health Care among office-based
physicians. The information will be
collected directly from physician

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