Proposed Data Collections Submitted for Public Comment and Recommendations, 18600-18601 [2013-07059]

Download as PDF 18600 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices TABLE 1—ESTIMATED ANNUALIZED BURDEN TABLE Average burden/ response (in hours) Number of responses/ respondent Number of respondents Response burden (in hours) Type of respondent Form name State Government Representatives .. State Government Representatives .. State Government Representatives .. Contact info verification .................... Telephone protocol .......................... Electronic file development .............. 34 34 34 1 1 1 5/60 30/60 2 3 17 68 Total ........................................... ........................................................... ........................ ........................ ........................ 88 Dated: March 21, 2013. Ron A. Otten, Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention. Proposed Project The Gonococcal Isolate Surveillance Project (GISP), OMB No. 0920–0307 exp. 12/31/2013—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). [FR Doc. 2013–07054 Filed 3–26–13; 8:45 am] BILLING CODE 4163–18–P Background and Brief Description DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–13–0307] mstockstill on DSK4VPTVN1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–7570 or send comments to Ron Otten, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. 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; and (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. Written comments should be received within 60 days of this notice. VerDate Mar<15>2010 18:10 Mar 26, 2013 Jkt 229001 The purpose of this request is to obtain Office of Budget and Management (OMB) approval to revise the data collection for the Gonococcal Isolate Surveillance Project (GISP) (OMB No. 0920–0307, expires 12/31/ 2013). CDC seeks a three-year approval to conduct the GISP project. Revisions to this ICR consist of removing 4 variables from the approved Form 1: Demographic and Clinical Data. The variables to be removed have not proven useful in the past and will not increase or decrease the burden. The objectives of GISP are: (1) To monitor trends in antimicrobial susceptibility of strains of Neisseria gonorrhoeae in the United States and (2) to characterize resistant isolates. Surveillance of N. gonorrhoeae antimicrobial resistance is important because: (1) Nearly all gonococcal infections are treated empirically and susceptibility testing data is not routinely available in clinical practice; (2) N. gonorrhoeae has consistently demonstrated the ability to develop resistance to the antimicrobials 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 critical national, regional, and sitespecific gonococcal antimicrobial resistance data. 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 susceptibility of the isolates to 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 1986–2012, 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. 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 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. E:\FR\FM\27MRN1.SGM 27MRN1 18601 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Notices 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). There are no additional costs to respondents. ESTIMATE OF ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Avg. burden per response (in hours) Total annual burden (in hours) Type of respondent Form name Clinic .............................. Laboratory ...................... Demographic Clinical Data Form 1 ..................... Antimicrobial Susceptibility Testing Form 2 ........ Control Strain Susceptibility Testing Form 3 ....... 30 5 5 240 1,452 48 11/60 1 12/60 1,320 7,260 48 Total ........................ .............................................................................. 40 ........................ ........................ 8,628 Dated: March 21, 2013. Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–07059 Filed 3–26–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention mstockstill on DSK4VPTVN1PROD with NOTICES Advisory Committee on Breast Cancer in Young Women (ACBCYW) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee: Time and Date: 9:00 a.m.–11:00 a.m. EDT, April 16, 2013. Place: The meeting will be held via teleconference. Teleconference login information is as follows: For Public: TOLL–FREE PHONE #: 800–857–4875 Participant passcode: 9377 Net Conference URL: https:// www.mymeetings.com/nc/join/ Conference number: PW8921926 Audience passcode: 9377 or Public can join the event directly: https:// www.mymeetings.com/nc/ join.php?i=PW8921926&p=9377&t=c There is also a toll number for anyone outside of the USA: TOLL #: 1–212–287–1661 Participant passcode: 9377 Please go to the ACBCYW meeting Web page to register for this meeting: https://www.cdc.gov/cancer/breast/ what_cdc_is_doing/conference.htm. VerDate Mar<15>2010 18:10 Mar 26, 2013 Jkt 229001 Status: Open to the public, limited only by the number of phone lines available. Purpose: The committee provides advice and guidance to the Secretary, HHS; the Assistant Secretary for Health; and the Director, CDC, regarding the formative research, development, implementation and evaluation of evidence-based activities designed to prevent breast cancer (particularly among those at heightened risk) and promote the early detection and support of young women who develop the disease. The advice provided by the Committee will assist in ensuring scientific quality, timeliness, utility, and dissemination of credible appropriate messages and resource materials. Matters To Be Discussed: The agenda will include discussions on approaches to increase awareness of clinicians/ practitioners regarding topics such as breast health, symptoms, diagnosis, and treatment of breast cancer in young women; and information needs and delivery mechanisms for women at higher risks for developing breast cancer. These discussions will be directed toward the final review and approval of formal recommendations on these topics. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Temeika L. Fairley, Ph.D., Designated Federal Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway NE., Mailstop K52, Atlanta, Georgia, 30341, Telephone (770) 488–4518, Fax (770) 488–4760, Email: acbcyw@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 meetings and other committee management activities, for both the Centers for Disease Control and Prevention, and Agency for Toxic Substances and Disease Registry. Dana Redford, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2013–06946 Filed 3–26–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Respirator Certification Fees; Public Meeting The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public meeting. AGENCY: SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting. The purpose of this meeting is to allow stakeholders to present information the impact of an increase on respirator fees on individual respirator manufacturers, the respirator market, or on those industries that rely on NIOSH approved respiratory equipment. DATES: April 30, 2013, 10 a.m. to 4 p.m. EDT, or after the last public commenter has spoken, whichever occurs first. ADDRESSES: U.S. Office of Surface Mining, Three Parkway Center E:\FR\FM\27MRN1.SGM 27MRN1

Agencies

[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18600-18601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07059]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-0307]

Proposed Data Collections Submitted for Public Comment and
Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
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; and (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. Written comments should be received
within 60 days of this notice.

Proposed Project

The Gonococcal Isolate Surveillance Project (GISP), OMB No. 0920-
0307 exp. 12/31/2013--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 purpose of this request is to obtain Office of Budget and
Management (OMB) approval to revise the data collection for the
Gonococcal Isolate Surveillance Project (GISP) (OMB No. 0920-0307,
expires 12/31/2013). CDC seeks a three-year approval to conduct the
GISP project. Revisions to this ICR consist of removing 4 variables
from the approved Form 1: Demographic and Clinical Data. The variables
to be removed have not proven useful in the past and will not increase
or decrease the burden. The objectives of GISP are: (1) To monitor
trends in antimicrobial susceptibility of strains of Neisseria
gonorrhoeae in the United States and (2) to characterize resistant
isolates. Surveillance of N. gonorrhoeae antimicrobial resistance is
important because: (1) Nearly all gonococcal infections are treated
empirically and susceptibility testing data is not routinely available
in clinical practice; (2) N. gonorrhoeae has consistently demonstrated
the ability to develop resistance to the antimicrobials 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 critical national,
regional, and site-specific gonococcal antimicrobial resistance data.
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 susceptibility of the isolates
to 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 1986-2012, 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.
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
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.

[[Page 18601]]

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). There are no additional costs to
respondents.

Estimate of Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Avg. burden Total annual
Type of respondent Form name Number of responses per per response burden (in
respondents respondent (in hours) 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...................................... ....................................... 40 .............. .............. 8,628
--------------------------------------------------------------------------------------------------------------------------------------------------------

Dated: March 21, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-07059 Filed 3-26-13; 8:45 am]
BILLING CODE 4163-18-P

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