Proposed Data Collections Submitted for Public Comment and Recommendations, 9923-9924 [2013-03196]

Download as PDF 9923 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Notices This project proposes to continue collecting information on individuals with ALS which can be combined with information obtained from existing sources of information and add additional optional risk factor surveys. This combined data will become the National ALS Registry and will be used to provide more accurate estimates of the incidence and prevalence of disease as well as the demographic characteristics of the cases. Information obtained from the surveys will be used to better characterize potential risk factors for ALS which will lead to further in-depth studies. The existence of the Web site has been advertised by ATSDR and advocacy groups such as the Amyotrophic Lateral Sclerosis Association (ALSA) and the Muscular Dystrophy Association (MDA). There are between 15,000 and 30,000 individuals living with ALS at any given time. In addition, approximately 6,000 people are diagnosed with ALS each year and we expect about onequarter of them will participate in the registry. Because an advantage to registration is participating in the surveys, we expect the one time surveys, and the twice yearly survey participation rate will be 50%. There are no costs to the respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name Person with ALS ................ Validation questions (Screener) for suspected ALS cases. Registration Form of ALS cases ..................... Cases of ALS completing 1-time surveys ...... Cases of ALS completing twice yearly surveys*. ......................................................................... Total ............................ Number of responses per respondent Average burden per response (in hours) Total burden (in hours) 1670 1 2/60 56 1500 750 750 1 16 2.7 7/60 5/60 5/60 175 1000 169 ........................ ........................ ........................ 1400 * The disease progression survey is taken initial and then 3 times the first year (3, 6, 12 months after the initial survey). Because some people’s disease progresses more rapidly, clinicians recommended adding the survey at 3 months to make sure everyone had the opportunity to take the survey a second time. In years 2 and 3, the survey would be taken at 6 and 12 months. Kimberly S. Lane, Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–03193 Filed 2–11–13; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention 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 Proposed Data Collections Submitted for Public Comment and Recommendations tkelley on DSK3SPTVN1PROD with NOTICES [60Day-13–13GX] Assessment of a Comprehensive Human immunodeficiency virus (HIV) Clinic-Based Intervention to Promote Patients’ Health and Reduce Transmission Risk—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). 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 VerDate Mar<15>2010 16:40 Feb 11, 2013 Jkt 229001 Background and Brief Description CDC is requesting Office of Management and Budget (OMB) approval to collect data that will be used to evaluate an HIV clinic-based intervention to increase the number of HIV patients who (1) have undetectable levels of HIV in their blood, (2) adhere optimally to antiretroviral therapy (ART), (3) attend clinic regularly for primary care, and (4) practice safer sex. These are objectives of the National PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 HIV/AIDS Strategy and goals of the strategic plan of the Division of HIV/ AIDS Prevention, Centers for Disease Control and Prevention. The project will be conducted at six HIV clinics in the United States. This proposed data collection will occur over 3 years. The intervention that is part of this project focuses primarily on HIV patients who have a detectable viral load, i.e., their viral load is not as low as it can be and is not fully controlled. The intervention components include: (1) Brief counseling from medical providers during primary care visits informed by a behavioral screener completed by patients; (2) a computerbased intervention (CBI) in which patients see short videos of HIV medical providers (not their own providers) talking about the importance of regular clinic attendance, adherence to ART, and safer sex; and (3) one-on-one counseling from a prevention specialist if needed. The following data will be collected in this project: • A data manager at each clinic will electronically transmit patient clinical data to CDC using a unique study identification code as the only means of identifying a patient’s data. The data files sent to CDC will not contain any medical record numbers, names, or social security numbers. The information will be encrypted and stored in a secure CDC server. The data E:\FR\FM\12FEN1.SGM 12FEN1 9924 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Notices collected from patients include (1) a behavioral screener self-administered by patients each time they have a primary care visit. Patients complete the screener in the waiting room before seeing their primary care provider. (2) CBI assessment items on demographic factors, clinic attendance, ART status, ART adherence, and sexual risk behavior that are completed before may have discussed with them at their medical visit (e.g., adherence, clinic attendance). • Data collected from primary care medical providers includes a quarterly survey asking them to indicate the types of topics/issues they discussed with their HIV patients. There are no costs to respondents other than their time. patients see the CBI videos. Patients with detectable viral loads will be asked to do the CBI three times, spaced approximately three months apart. Patients’ CBI responses are not shared with their clinic providers. (3) On a quarterly basis, 50 patients at each clinic will be asked to complete a brief exit survey after their medical exam, asking about topics that the provider ESTIMATED ANNUALIZED BURDEN HOURS Form name Data manager at clinic .. Electronic transmittal of clinical variables archived in clinic databases (no form). Behavioral screener (patients with detectable or undetectable VL; paper form). CBI assessment items for patients with detectable VL (electronic form). Patient exit survey (electronic form) .................... Provider survey (electronic form) ........................ .............................................................................. Patient ............................ Patient ............................ Patient ............................ Primary care provider .... Total ........................ Kimberly S. Lane, Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–03196 Filed 2–11–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60-Day–13–0743] tkelley on DSK3SPTVN1PROD 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 Kimberly Lane, 1600 Clifton Road, MS D–74, 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 VerDate Mar<15>2010 16:40 Feb 11, 2013 Jkt 229001 Number of responses per respondent Number of respondents Type of respondent 4 24 576 6,315 4 5/60 2,105 2,069 3 10/60 1,035 1,200 120 ........................ 1 4 ........................ 5/60 10/60 ........................ 100 80 3,896 Proposed Project Assessment and Monitoring of Breastfeeding-Related Maternity Care Practices in Intra-partum Care Facilities in the United States and Territories (OMB Control No. 0920–0743, Exp. 12/ 31/2011)—Reinstatement—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Substantial evidence demonstrates the social, economic, and health benefits of breastfeeding for both the mother and infant as well as for society in general. Breastfeeding mothers have lower risks of breast and ovarian cancers and type 2 diabetes, and breastfeeding better protects infants against infections, chronic diseases like diabetes and obesity, and even childhood leukemia and sudden infant death syndrome (SIDS). However, the groups that are at higher risk for diabetes, obesity, and poor health overall, persistently have the lowest breastfeeding rates. Frm 00042 Fmt 4703 Total burden hours 6 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. PO 00000 Average burden per response (hours) Sfmt 4703 Health professionals recommend at least 12 months of breastfeeding, and Healthy People 2020 establishes specific national breastfeeding goals. In addition to increasing overall rates, a significant public health priority in the United States (U.S.) is to reduce variation in breastfeeding rates across population subgroups. Although CDC surveillance data indicate that breastfeeding initiation rates in the U.S. are climbing, rates for duration and exclusivity continue to lag, and significant disparities in breastfeeding rates persist between African-American and white women. The health care system is one of the most important and effective settings to improve breastfeeding initiation rates because hospital practices strongly influence infant feeding outcomes. In 2003, CDC convened a panel of experts in surveillance and monitoring of hospital practices related to breastfeeding to identify the most effective way for CDC to address the urgent public health need for nationally representative data on these practices. The Expert Panel’s consensus recommendation was to establish an ongoing, national system to monitor and evaluate hospital practices related to breastfeeding among all facilities that routinely provide intrapartum care in the United States. In response to this input, CDC created the first national survey of Maternity Practices in Infant Nutrition and Care (known as the mPINC Survey) in health care facilities (hospitals and free-standing birth centers). The mPINC survey was first E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9923-9924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03196]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13GX]

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

Assessment of a Comprehensive Human immunodeficiency virus (HIV)
Clinic-Based Intervention to Promote Patients' Health and Reduce
Transmission Risk--New--National Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).

Background and Brief Description

CDC is requesting Office of Management and Budget (OMB) approval to
collect data that will be used to evaluate an HIV clinic-based
intervention to increase the number of HIV patients who (1) have
undetectable levels of HIV in their blood, (2) adhere optimally to
antiretroviral therapy (ART), (3) attend clinic regularly for primary
care, and (4) practice safer sex. These are objectives of the National
HIV/AIDS Strategy and goals of the strategic plan of the Division of
HIV/AIDS Prevention, Centers for Disease Control and Prevention.
The project will be conducted at six HIV clinics in the United
States. This proposed data collection will occur over 3 years.
The intervention that is part of this project focuses primarily on
HIV patients who have a detectable viral load, i.e., their viral load
is not as low as it can be and is not fully controlled. The
intervention components include: (1) Brief counseling from medical
providers during primary care visits informed by a behavioral screener
completed by patients; (2) a computer-based intervention (CBI) in which
patients see short videos of HIV medical providers (not their own
providers) talking about the importance of regular clinic attendance,
adherence to ART, and safer sex; and (3) one-on-one counseling from a
prevention specialist if needed.
The following data will be collected in this project:
A data manager at each clinic will electronically transmit
patient clinical data to CDC using a unique study identification code
as the only means of identifying a patient's data. The data files sent
to CDC will not contain any medical record numbers, names, or social
security numbers. The information will be encrypted and stored in a
secure CDC server. The data

[[Page 9924]]

collected from patients include (1) a behavioral screener self-
administered by patients each time they have a primary care visit.
Patients complete the screener in the waiting room before seeing their
primary care provider. (2) CBI assessment items on demographic factors,
clinic attendance, ART status, ART adherence, and sexual risk behavior
that are completed before patients see the CBI videos. Patients with
detectable viral loads will be asked to do the CBI three times, spaced
approximately three months apart. Patients' CBI responses are not
shared with their clinic providers. (3) On a quarterly basis, 50
patients at each clinic will be asked to complete a brief exit survey
after their medical exam, asking about topics that the provider may
have discussed with them at their medical visit (e.g., adherence,
clinic attendance).
Data collected from primary care medical providers
includes a quarterly survey asking them to indicate the types of
topics/issues they discussed with their HIV patients.

There are no costs to respondents other than their time.

Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data manager at clinic......................... Electronic transmittal of clinical 6 4 24 576
variables archived in clinic databases
(no form).
Patient........................................ Behavioral screener (patients with 6,315 4 5/60 2,105
detectable or undetectable VL; paper
form).
Patient........................................ CBI assessment items for patients with 2,069 3 10/60 1,035
detectable VL (electronic form).
Patient........................................ Patient exit survey (electronic form).. 1,200 1 5/60 100
Primary care provider.......................... Provider survey (electronic form)...... 120 4 10/60 80
Total...................................... ....................................... .............. .............. .............. 3,896
--------------------------------------------------------------------------------------------------------------------------------------------------------

Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013-03196 Filed 2-11-13; 8:45 am]
BILLING CODE 4163-18-P

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