Agency Forms Undergoing Paperwork Reduction Act Review, 70190-70192 [2014-27851]

Download as PDF 70190 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices instruments, and the collection of critical data. This request is for a new generic approval to conduct information collections during DORIs. A three-year clearance is requested to ensure: (1) Rapid deployment of data collection tools and (2) timely information collection of vital information. Of particular interest is response to increasing trends in, or changing characteristics of, overdose from prescription drugs (with a special interest in opioid analgesics such as oxycodone or methadone; benzodiazepines such as alprazolam) and/or illicit drugs (e.g., heroin). Specifically, this request covers investigative collections with the following aims: (1) To understand sudden increases in drug use and misuse associated with fatal and nonfatal overdoses; (2) to understand the drivers and risk factors associated with those trends; and (3) to identify the groups most affected. This will allow CDC to effectively advise states on recommended actions to control local epidemics. Thus, the ultimate goals of these collections are to minimize adverse health consequences, provide epidemiological data collection support to the states and, based on the findings from the investigation, appropriately assist with implementation of prevention and control measures. Data is collected by epidemiologists, psychologists, medical professionals, subject matter experts, and biostatisticians. Examples of data collection modes that may be employed during DORIs include: Archival record abstractions and reviews, face-to-face interviews, telephone interviews, webbased questionnaires, and selfadministered questionnaires. For example, information collected through archival chart review from hospitals and medical examiners could include demographics, drug use history, reported medical and mental health conditions, place of overdose, place of death, drug paraphernalia on the scene, mode of administration, observers present, naloxone administration, hospital admittance, autopsy findings, and toxicology results. Information collected through interviews with representatives from agencies involved in preventing, intervening, or responding to drug overdose could include professional history, personal experience with drug overdose cases or investigations, prevention or intervention efforts engaged in, and perceptions of characteristics of, or changes in drug overdose cases (e.g., transition from opioids to heroin; increasing or decreasing rates). Collection of information from nonfatal overdose victims, and friends and family of overdose victims could include substance use history, prescription drug history, number of providers and pharmacies used, pain history, co-occurring health conditions (e.g., abnormal snoring indicative of respiratory depression), mental health conditions (e.g., depression, anxiety disorders), enrollment in drug treatment programs, sources of drugs, route of drug administration, and criminal history. Finally, collection of spatial information could be obtained through city, county, and state government agencies to determine structural and environmental factors associated with location of overdose deaths. Respondent type will also vary by investigation, but will include organizations typically involved in prevention, intervention, and response to drug overdose (e.g., public health, law enforcement authorities, health systems, and community organizations). Respondents also may include victims of non-fatal drug overdoses, as well as family and friends of victims. During a DORI, data is collected once, with the rare need for follow-up. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Drug Overdose Response Investigation Participants. Drug Overdose Response Investigation Data Collection Instruments. 2,700 1 .5 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. 2014–27850 Filed 11–24–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES wreier-aviles on DSK4TPTVN1PROD with NOTICES Centers for Disease Control and Prevention [30Day–15–0913] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. E:\FR\FM\25NON1.SGM 25NON1 70191 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices Proposed Project Evaluating Locally-Developed HIV Prevention Interventions for AfricanAmerican MSM in Los Angeles (OMB No. 0920–0913, expires 01/15/2015)— [Extension]—National Center for HIV/ AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Data on HIV cases reported in 33 U.S. states with HIV reporting indicate the burden of HIV/AIDS is most concentrated in the African American population compared to other racial/ ethnic groups. Of the 49,704 African American males diagnosed with HIV between 2001 and 2004, 54% of these cases were among men who have sex with men (MSM). In Los Angeles County (LAC), the proportion of HIV/ AIDS cases among African American males attributable to male-to-male sexual transmission is even greater (75%). In the absence of an effective vaccine, behavioral interventions represent one of the few methods for reducing high HIV incidence among African American MSM (AAMSM). Unfortunately, in the third decade of the epidemic, very few of the available HIVprevention interventions for African American populations have been designed specifically for MSM. In fact, until very recently none of CDC’s evidence-based, HIV-prevention interventions had been specifically tested for efficacy in reducing HIV transmission among MSM of color. Given the conspicuous absence of (1) evidence-based HIV interventions and (2) outcome evaluations of existing AAMSM interventions, our collaborative team intends to address a glaring research gap by implementing a best-practices model of comprehensive program evaluation. As of November 7, 2014, 888 men were screened using the eligibility screener, 711 were eligible, and 520 men were consented, enrolled, and completed the baseline assessment. There are a total of 227 men who completed 3-month follow-up and 193 men who completed 6-month follow-up. Each enrolled participant completed a client satisfaction survey for each of the three intervention sessions they attended. Finally, twenty-two men consented for and completed qualitative interviews. There were unanticipated delays in getting our initial OMB approval and delays in enrollment which prevented the study from reaching the desired sample size of 528 and completing data collection within the original 3-year timeframe. When the current information collection request (ICR) expires on January 31st, 2015, we will need to enroll, consent, and baseline approximately 10 more participants. To reach these additional 10 participants, we anticipate having to screen approximately more 20 men. During this extended period, an additional 185 men will complete the 3month assessment, 225 men will complete the 6-month follow-up questionnaires, and 14 men will consent for and complete the success case study qualitative interviews. We anticipate that all data collection activities will be completed by the end of 2015. The purpose of this project is to test in a real world setting the efficacy of an HIV transmission prevention intervention for reducing sexual risk among African American men who have sex with men in Los Angeles County. The intervention is a 3-session, group- level intervention that will provide participants with the information, motivation, and skills necessary to reduce their risk of transmitting or acquiring HIV. The intervention is being evaluated using baseline, 3 month and 6 month follow up assessments. This project is also conducting in-depth qualitative interviews with a total of 36 men in order to assess the experiences with the intervention, elicit recommendations for improving the intervention, and to better understand the factors that put young African American MSM at risk for HIV. CDC is requesting approval for a 1year clearance to complete data collection. The data collection system involves screenings, limited locator information, contact information, baseline questionnaire, client satisfaction surveys, 3-month follow-up questionnaire, 6-month follow-up questionnaire, and case study interviews. An estimated 20 men will be screened for eligibility in order to enroll 10 additional men to reach the desired sample size of 528. The baseline and follow up questionnaires contain questions about participants’ sociodemographic information, health and healthcare, sexual activity, substance use, and other psychosocial issues. The duration of each baseline, 3-month, and 6-month questionnaires are estimated to be 60 minutes; the Success Case Study interviews 90 minutes; Outreach Recruitment Assessment 5 minutes; limited locator information form 5 minutes; participant contact information form 10 minutes; each client satisfaction survey 5 minutes. There is no cost to participants other than their time. The total estimated annual burden hours are 459. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents wreier-aviles on DSK4TPTVN1PROD with NOTICES Type of respondent Form name Prospective Participant .................... Prospective Participant .................... Enrolled Participant .......................... Enrolled Participant .......................... Enrolled Participant .......................... Enrolled Participant .......................... Enrolled Participant .......................... Enrolled Participant .......................... Enrolled Participant .......................... Enrolled Participant .......................... Outreach Recruitment Assessment (screener) ............ Limited Locator Form .................................................... RCT Informed Consent Form ....................................... Participant Contact Information Form ........................... Baseline Questionnaire ................................................. Client Satisfaction Survey ............................................. 3 month follow up Questionnaire .................................. 6 month follow up Questionnaire .................................. Success Case Study Informed Consent Form ............. Success Case Study Interview ..................................... VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\25NON1.SGM Number of responses per respondent 20 20 10 10 10 30 185 225 14 14 25NON1 1 1 1 1 1 3 1 1 1 1 Average burden per respondent (in hours) 5/60 5/60 10/60 10/60 1 5/60 1 1 10/60 1.5 70192 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices 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. 2014–27851 Filed 11–24–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, Office of Public Health Preparedness and Response: Notice of Charter Amendment This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Board of Scientific Counselors, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), has amended their charter to add the Tribal Epidemiology Centers as a non-voting liaison representative. The amended filing date is November 5, 2014. For information, contact Samuel Groseclose, DVM, MPH, Board of Scientific Counselors, Office of Public Health and Preparedness and Response, Department of Health and Human Services, CDC, 1600 Clifton Road NE., Mailstop D44, Atlanta, Georgia, 30333, telephone (404) 639–0637, or fax (404) 639–7977. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. 2014–27837 Filed 11–24–14; 8:45 am] wreier-aviles on DSK4TPTVN1PROD with NOTICES BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The meeting announced below concerns Cooperative Research Agreements in the area of Agricultural, Forestry, and Fishing Safety and Health Research, PAR–14–175, initial review. 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 aforementioned meeting: Times and Dates 1:00 p.m.–5:00 p.m., January 21, 2015 (Closed). 1:00 p.m.–5:00 p.m., January 22, 2015 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Agricultural, Forestry, and Fishing Safety and Health Research, PAR– 14–175’’. Contact Person for More Information: Nina Turner, Ph.D., Scientific Review Officer, CDC/NIOSH, 1095 Willowdale Road, Morgantown, WV, 26506, Telephone: (304) 285–5976. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2014–27838 Filed 11–24–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Interagency Committee on Smoking and Health (ICSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub.L. 92–463), the Centers for Disease Control and Prevention announces the VerDate Sep<11>2014 14:41 Nov 24, 2014 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 following meeting of the aforementioned committee. Time and Date: 9:00 a.m.–4:30 p.m., December 16, 2014. Place: Capital Hilton, Federal AB Rooms located at 1001 16th Street NW., Washington, DC 20036. Telephone: (202) 393–1000. Status: Open to the public, limited only by the space and telephone lines available. Participants that would like to attend in person are encouraged to register with the contact person listed below. If you will require a sign language interpreter, or have other special needs, please notify the contact person by 4:30 p.m. EST on December 11, 2014. Limited teleconference access is also available. Login information is as follows: Toll Free Phone#: (800) 779–4815. For Public: Conference number: PW9452765. Participant passcode: 3074156. Participant URL: https:// www.mymeetings.com/nc/join/. Participants can join the event directly at: https://www.mymeetings.com/nc/ join.php?i=PW9452765&p=3074156&t=c. Purpose: The committee advises the Secretary, Department of Health and Human Services, and the Assistant Secretary for Health in the (a) coordination of all research and education programs and other activities within the Department and with other federal, state, local and private agencies, and (b) establishment and maintenance of liaison with appropriate private entities, federal agencies, and state and local public health agencies with respect to smoking and health activities. Matters for Discussion: The topic of the meeting is ‘‘Preventing and Reducing Tobacco Use in Youth and Young Adults’’ and the objective is to identify specific federal actions that can be taken to prevent 5.6 million premature deaths from tobacco use among today’s youth. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Substantive program information as well as summaries of the meeting and roster of committee members may be obtained from the Internet at www.cdc.gov/tobacco or from Ms. Monica L. Swann, Management and Program Analyst, National Center for Chronic Disease Prevention and Health Promotion, CDC, 395 E. Street SW., Washington, DC 20024. Telephone: (202) 245–0552. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine Baker, Director, Management Analysis and Service Office, Centers for Disease Control and Prevention. [FR Doc. 2014–27836 Filed 11–24–14; 8:45 am] BILLING CODE 4163–18–P E:\FR\FM\25NON1.SGM 25NON1

Agencies

[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70190-70192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27851]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0913]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

[[Page 70191]]

Proposed Project

    Evaluating Locally-Developed HIV Prevention Interventions for 
African-American MSM in Los Angeles (OMB No. 0920-0913, expires 01/15/
2015)--[Extension]--National Center for HIV/AIDS, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Data on HIV cases reported in 33 U.S. states with HIV reporting 
indicate the burden of HIV/AIDS is most concentrated in the African 
American population compared to other racial/ethnic groups. Of the 
49,704 African American males diagnosed with HIV between 2001 and 2004, 
54% of these cases were among men who have sex with men (MSM). In Los 
Angeles County (LAC), the proportion of HIV/AIDS cases among African 
American males attributable to male-to-male sexual transmission is even 
greater (75%). In the absence of an effective vaccine, behavioral 
interventions represent one of the few methods for reducing high HIV 
incidence among African American MSM (AAMSM). Unfortunately, in the 
third decade of the epidemic, very few of the available HIV-prevention 
interventions for African American populations have been designed 
specifically for MSM. In fact, until very recently none of CDC's 
evidence-based, HIV-prevention interventions had been specifically 
tested for efficacy in reducing HIV transmission among MSM of color. 
Given the conspicuous absence of (1) evidence-based HIV interventions 
and (2) outcome evaluations of existing AAMSM interventions, our 
collaborative team intends to address a glaring research gap by 
implementing a best-practices model of comprehensive program 
evaluation.
    As of November 7, 2014, 888 men were screened using the eligibility 
screener, 711 were eligible, and 520 men were consented, enrolled, and 
completed the baseline assessment. There are a total of 227 men who 
completed 3-month follow-up and 193 men who completed 6-month follow-
up. Each enrolled participant completed a client satisfaction survey 
for each of the three intervention sessions they attended. Finally, 
twenty-two men consented for and completed qualitative interviews. 
There were unanticipated delays in getting our initial OMB approval and 
delays in enrollment which prevented the study from reaching the 
desired sample size of 528 and completing data collection within the 
original 3-year timeframe. When the current information collection 
request (ICR) expires on January 31st, 2015, we will need to enroll, 
consent, and baseline approximately 10 more participants. To reach 
these additional 10 participants, we anticipate having to screen 
approximately more 20 men. During this extended period, an additional 
185 men will complete the 3-month assessment, 225 men will complete the 
6-month follow-up questionnaires, and 14 men will consent for and 
complete the success case study qualitative interviews. We anticipate 
that all data collection activities will be completed by the end of 
2015.
    The purpose of this project is to test in a real world setting the 
efficacy of an HIV transmission prevention intervention for reducing 
sexual risk among African American men who have sex with men in Los 
Angeles County. The intervention is a 3-session, group-level 
intervention that will provide participants with the information, 
motivation, and skills necessary to reduce their risk of transmitting 
or acquiring HIV. The intervention is being evaluated using baseline, 3 
month and 6 month follow up assessments. This project is also 
conducting in-depth qualitative interviews with a total of 36 men in 
order to assess the experiences with the intervention, elicit 
recommendations for improving the intervention, and to better 
understand the factors that put young African American MSM at risk for 
HIV.
    CDC is requesting approval for a 1-year clearance to complete data 
collection. The data collection system involves screenings, limited 
locator information, contact information, baseline questionnaire, 
client satisfaction surveys, 3-month follow-up questionnaire, 6-month 
follow-up questionnaire, and case study interviews. An estimated 20 men 
will be screened for eligibility in order to enroll 10 additional men 
to reach the desired sample size of 528. The baseline and follow up 
questionnaires contain questions about participants' socio-demographic 
information, health and healthcare, sexual activity, substance use, and 
other psychosocial issues. The duration of each baseline, 3-month, and 
6-month questionnaires are estimated to be 60 minutes; the Success Case 
Study interviews 90 minutes; Outreach Recruitment Assessment 5 minutes; 
limited locator information form 5 minutes; participant contact 
information form 10 minutes; each client satisfaction survey 5 minutes.
    There is no cost to participants other than their time. The total 
estimated annual burden hours are 459.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per  per respondent
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Prospective Participant...............  Outreach Recruitment                  20               1            5/60
                                         Assessment (screener).
Prospective Participant...............  Limited Locator Form....              20               1            5/60
Enrolled Participant..................  RCT Informed Consent                  10               1           10/60
                                         Form.
Enrolled Participant..................  Participant Contact                   10               1           10/60
                                         Information Form.
Enrolled Participant..................  Baseline Questionnaire..              10               1               1
Enrolled Participant..................  Client Satisfaction                   30               3            5/60
                                         Survey.
Enrolled Participant..................  3 month follow up                    185               1               1
                                         Questionnaire.
Enrolled Participant..................  6 month follow up                    225               1               1
                                         Questionnaire.
Enrolled Participant..................  Success Case Study                    14               1           10/60
                                         Informed Consent Form.
Enrolled Participant..................  Success Case Study                    14               1             1.5
                                         Interview.
----------------------------------------------------------------------------------------------------------------



[[Page 70192]]

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. 2014-27851 Filed 11-24-14; 8:45 am]
BILLING CODE 4163-18-P