82_FR_16466 82 FR 16403 - Agency Forms Undergoing Paperwork Reduction Act Review

82 FR 16403 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 63 (April 4, 2017)

Page Range16403-16404
FR Document2017-06577

Federal Register, Volume 82 Issue 63 (Tuesday, April 4, 2017) 
[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Notices]
[Pages 16403-16404]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-17AX]


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.

Proposed Project

    Mobile Messaging Intervention to Present New HIV Prevention Options 
for Men Who have Sex with Men (MSM) Study--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    Public health approaches to HIV prevention and control are 
increasingly complex for men who have sex with men (MSM), a population 
with a disproportionately high burden of HIV infection. In addition to 
the established biomedical treatments for HIV-positive MSM, and 
behavioral strategies to reduce the risk of transmitting or contracting 
HIV, current recommendations incorporate the breakthrough biomedical 
risk reduction

[[Page 16404]]

strategy of pre-exposure prophylaxis (PrEP) for HIV-negative MSM who 
are at high risk of contracting HIV. For maximum efficacy, health 
communications about HIV prevention and control should be delivered to 
MSM according to their HIV serostatus and risk category.
    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention is requesting approval to evaluate the efficacy of a 
smartphone-based HIV prevention intervention for MSM, known as M\3\(M-
Cubed) that has been designed to deliver targeted messages in six 
intervention domains: HIV testing, sexually transmitted infection (STI) 
testing, PrEP, antiretroviral (ARV) treatment, Condoms, and Engagement 
in Care. The smartphone and tablet application includes 36 core 
messages and 12 videos that were developed based on CDC-sponsored 
iterative formative research (OMB No. 0920-0840) and a review of HIV 
health communications literature. Messages will be delivered to each 
participant's device. The proposed study will assess whether exposure 
to the message-delivery platform results in improvements in 
participants' self-reported sexual health and HIV prevention behaviors, 
beliefs and attitudes. Information will be collected at baseline and 3-
month, 6-month, and 9-month follow-ups.
    The study population will include 1,206 adult MSM living in 
Atlanta, GA, Detroit, MI and New York City, NY. These study sites were 
selected not only because they have high rates of HIV, but also because 
significant disparities in HIV among men who have sex with men (MSM) 
have been observed by race/ethnicity and age. Study participants will 
be sexually active MSM at least 18 years in age who own and use and 
Android and iOS smartphone. Study participants will be stratified by 
risk category: HIV positive (one third) and HIV negative (one third 
each: condomless anal sex in past three months; no condomless anal sex 
past three months). Across the three sites, we will ensure that at 
least 40% of participants are people of color (non-white or Hispanic) 
by quota sampling. Participants will be recruited to the study through 
a combination of approaches, including online advertisement, 
traditional print advertisement, referral, in-person outreach, and 
through word of mouth. Participants will be randomly assigned to an 
intervention group or a waitlist control group. The control group will 
receive the intervention after the study has been completed.
    A quantitative assessment questionnaire will be administered online 
at four points in time. The assessment will be used to measure changes 
in condom use behavior, number of sex partners, HIV testing, sexually 
transmitted disease (STD) testing, health care engagement, pre-exposure 
prophylaxis uptake and adherence, and antiretroviral therapy uptake and 
adherence following completion of the intervention. Participants will 
complete the assessment in-person at baseline and 9-months, using a 
computer in a private location, and remotely via their personal 
computer or tablet device at the 3-month and 6-month follow-ups. The 
same information will be collected from all participants. The burden 
per response for each assessment is 1.5 hours.
    It is expected that 50% of men screened will meet study eligibility 
and provide contact information, that 75 percent will schedule and show 
up for an in-person appointment, and that 95 percent of these men will 
remain eligible after reverification. We expect the initial screening 
to take approximately four minutes to complete, that providing contact 
information will take 1 minute, and the rescreening prior to study 
enrollment to take another four minutes.
    OMB approval is requested for two years. Participation is voluntary 
and there are no costs to the respondents other than their time. The 
total estimated annual burden is 3,787 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                   Form name             respondents   responses  per   response  (in
                                                                                     respondent       hours)
----------------------------------------------------------------------------------------------------------------
Men >= 18 Years of Age Who Have Sex  Participant Screening                 1,693               1            4/60
 With Men.                            (Eligibility).
                                     Contact Information Form...             847               1            1/60
                                     Participant Screening                   635               1            4/60
                                      (Verification).
                                     Assessment.................             603               4             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. 2017-06577 Filed 4-3-17; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices 16403 potentially limiting the competitiveness Relief (PEPFAR); GH17–003, (OMB) for review and approval in of the divested clinics. Third, to ensure Conducting Public Health Research in accordance with the Paperwork continuity of patient care and records as South Africa; and GH17–004, Reduction Act of 1995. The notice for the buyer implements its quality care, Conducting Public Health Research the proposed information collection is billing, and supply systems, the Consent Activities in Egypt. published to obtain comments from the Agreement requires DaVita to provide Times and Dates: 9:00 a.m.–2:00 p.m., public and affected agencies. transition services for a period up to EDT, April 25, 2017 (Closed), 9:00 a.m.– Written comments and suggestions twenty-four months. Firewalls and 2:00 p.m., EDT, April 26, 2017 (Closed). from the public and affected agencies confidentiality agreements will prevent Place: Teleconference. concerning the proposed collection of the exchange of competitively sensitive Status: The meeting will be closed to information are encouraged. Your information. Fourth, the Consent the public in accordance with comments should address any of the Agreement requires DaVita to provide provisions set forth in Section following: (a) Evaluate whether the the buyer with a license to Renal 552b(c)(4) and (6), Title 5 U.S.C., and proposed collection of information is Ventures’ policies, procedures, and the Determination of the Director, necessary for the proper performance of medical protocols, as well as the option Management Analysis and Services the functions of the agency, including to obtain and use DaVita’s medical Office, CDC, pursuant to Public Law 92– whether the information will have protocols, policies, and procedures, to 463. practical utility; (b) Evaluate the help with continuity of care for the Matters for Discussion: The meeting accuracy of the agencies estimate of the divested clinics’ patients. will include the initial review, burden of the proposed collection of The Consent Agreement requires discussion, and evaluation of information, including the validity of DaVita to provide notice to the applications received in response to the methodology and assumptions used; Commission prior to any acquisitions of ‘‘Program Development and Research to (c) Enhance the quality, utility, and dialysis clinics in the markets addressed Establish and Evaluate Innovative and clarity of the information to be by the Consent Agreement to ensure that Emerging Best Practices in Clinical and collected; (d) Minimize the burden of subsequent acquisitions do not Community Services through the the collection of information on those adversely impact competition in those President’s Emergency Plan for AIDS who are to respond, including through markets or undermine the remedial Relief (PEPFAR), FOA GH17–002; the use of appropriate automated, goals of the proposed order. Finally, the ‘‘Conducting Public Health Research in electronic, mechanical, or other Consent Agreement allows the South Africa’’, FOA GH17–003,; and technological collection techniques or Commission to appoint a monitor to ‘‘Conducting Public Health Research other forms of information technology, oversee DaVita’s compliance with the Activities in Egypt’’, FOA GH17–004. e.g., permitting electronic submission of Consent Agreement. Contact Person for More Information: responses; and (e) Assess information The purpose of this analysis is to collection costs. Hylan Shoob, Scientific Review Officer, facilitate public comment on the To request additional information on Center for Global Health (CGH) Science Consent Agreement, and it is not the proposed project or to obtain a copy Office, CGH, CDC, 1600 Clifton Road, intended to constitute an official of the information collection plan and NE., Mailstop D–69, Atlanta, Georgia interpretation of the proposed Decision instruments, call (404) 639–7570 or 30033, Telephone: (404) 639–4796. and Order, or to modify its terms in any send an email to omb@cdc.gov. Written The Director, Management Analysis way. comments and/or suggestions regarding and Services Office, has been delegated By direction of the Commission. the authority to sign Federal Register the items contained in this notice Donald S. Clark, notices pertaining to announcements of should be directed to the Attention: Secretary. meetings and other committee CDC Desk Officer, Office of Management [FR Doc. 2017–06556 Filed 4–3–17; 8:45 am] management activities, for both the and Budget, Washington, DC 20503 or Centers for Disease Control and by fax to (202) 395–5806. Written BILLING CODE 6750–01–P Prevention and the Agency for Toxic comments should be received within 30 Substances and Disease Registry. days of this notice. DEPARTMENT OF HEALTH AND Elaine L. Baker, Proposed Project HUMAN SERVICES Director, Management Analysis and Services Mobile Messaging Intervention to Office Centers for Disease Control and Present New HIV Prevention Options for Centers for Disease Control and Prevention. Men Who have Sex with Men (MSM) Prevention [FR Doc. 2017–06537 Filed 4–3–17; 8:45 am] Study—New—National Center for HIV/ Disease, Disability, and Injury BILLING CODE 4163–18–P AIDS, Viral Hepatitis, STD, and TB Prevention and Control Special Prevention (NCHHSTP), Centers for Emphasis Panel (SEP): Initial Review Disease Control and Prevention (CDC). DEPARTMENT OF HEALTH AND Background and Brief Description In accordance with Section 10(a)(2) of HUMAN SERVICES the Federal Advisory Committee Act Public health approaches to HIV (Pub. L. 92–463), the Centers for Disease Centers for Disease Control and prevention and control are increasingly Control and Prevention (CDC) Prevention complex for men who have sex with announces a meeting for the initial men (MSM), a population with a asabaliauskas on DSK3SPTVN1PROD with NOTICES [30Day–17–17AX] disproportionately high burden of HIV review of applications in response to Funding Opportunity Announcement Agency Forms Undergoing Paperwork infection. In addition to the established (FOA) GH17–002, Program Reduction Act Review biomedical treatments for HIV-positive Development and Research to Establish MSM, and behavioral strategies to and Evaluate Innovative and Emerging The Centers for Disease Control and reduce the risk of transmitting or Best Practices in Clinical and Prevention (CDC) has submitted the contracting HIV, current Community Services through the following information collection request recommendations incorporate the President’s Emergency Plan for AIDS to the Office of Management and Budget breakthrough biomedical risk reduction VerDate Sep<11>2014 16:21 Apr 03, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1

16404 Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Notices strategy of pre-exposure prophylaxis The study population will include changes in condom use behavior, (PrEP) for HIV-negative MSM who are at 1,206 adult MSM living in Atlanta, GA, number of sex partners, HIV testing, high risk of contracting HIV. For Detroit, MI and New York City, NY. sexually transmitted disease (STD) maximum efficacy, health These study sites were selected not only testing, health care engagement, pre- communications about HIV prevention because they have high rates of HIV, but exposure prophylaxis uptake and and control should be delivered to MSM also because significant disparities in adherence, and antiretroviral therapy according to their HIV serostatus and HIV among men who have sex with men uptake and adherence following risk category. (MSM) have been observed by race/ completion of the intervention. The National Center for HIV/AIDS, ethnicity and age. Study participants Participants will complete the Viral Hepatitis, STD and TB Prevention will be sexually active MSM at least 18 assessment in-person at baseline and 9- is requesting approval to evaluate the years in age who own and use and months, using a computer in a private efficacy of a smartphone-based HIV Android and iOS smartphone. Study location, and remotely via their personal prevention intervention for MSM, participants will be stratified by risk computer or tablet device at the 3- known as M3(M-Cubed) that has been category: HIV positive (one third) and month and 6-month follow-ups. The designed to deliver targeted messages in HIV negative (one third each: same information will be collected from six intervention domains: HIV testing, condomless anal sex in past three all participants. The burden per sexually transmitted infection (STI) months; no condomless anal sex past response for each assessment is 1.5 testing, PrEP, antiretroviral (ARV) three months). Across the three sites, we hours. treatment, Condoms, and Engagement in will ensure that at least 40% of It is expected that 50% of men Care. The smartphone and tablet participants are people of color (non- screened will meet study eligibility and application includes 36 core messages white or Hispanic) by quota sampling. provide contact information, that 75 and 12 videos that were developed Participants will be recruited to the percent will schedule and show up for based on CDC-sponsored iterative study through a combination of an in-person appointment, and that 95 formative research (OMB No. 0920– approaches, including online percent of these men will remain 0840) and a review of HIV health advertisement, traditional print eligible after reverification. We expect communications literature. Messages advertisement, referral, in-person the initial screening to take will be delivered to each participant’s outreach, and through word of mouth. approximately four minutes to device. The proposed study will assess Participants will be randomly assigned complete, that providing contact whether exposure to the message- to an intervention group or a waitlist information will take 1 minute, and the delivery platform results in control group. The control group will rescreening prior to study enrollment to improvements in participants’ self- receive the intervention after the study take another four minutes. reported sexual health and HIV has been completed. OMB approval is requested for two prevention behaviors, beliefs and A quantitative assessment years. Participation is voluntary and attitudes. Information will be collected questionnaire will be administered there are no costs to the respondents at baseline and 3-month, 6-month, and online at four points in time. The other than their time. The total 9-month follow-ups. assessment will be used to measure estimated annual burden is 3,787 hours. ESTIMATED ANNUALIZED BURDEN HOURS Number of Average Number of responses burden per Type of respondent Form name respondents per response respondent (in hours) Men ≥ 18 Years of Age Who Have Sex With Participant Screening (Eligibility) ................... 1,693 1 4/60 Men. Contact Information Form .............................. 847 1 1/60 Participant Screening (Verification) ................ 635 1 4/60 Assessment .................................................... 603 4 1.5 Leroy A. Richardson, DEPARTMENT OF HEALTH AND Geographic Disparities in Diabetes and Chief, Information Collection Review Office, HUMAN SERVICES Cardiometabolic Health. Office of Scientific Integrity, Office of the Times and Dates: Associate Director for Science, Office of the Centers for Disease Control and 10:00 a.m.–6:00 p.m., EDT, April 25, Director, Centers for Disease Control and Prevention 2017 (Closed) Prevention. 10:00 a.m.–6:00 p.m., EDT, April 26, [FR Doc. 2017–06577 Filed 4–3–17; 8:45 am] Disease, Disability, and Injury 2017 (Closed) BILLING CODE 4163–18–P Prevention and Control Special Emphasis Panel (SEP): Initial Review Place: Teleconference. Status: The meeting will be closed to In accordance with Section 10(a)(2) of the public in accordance with asabaliauskas on DSK3SPTVN1PROD with NOTICES the Federal Advisory Committee Act provisions set forth in Section 552b(c) (Pub. L. 92–463), the Centers for Disease (4) and (6), Title 5 U.S.C., and the Control and Prevention (CDC) Determination of the Director, announces a meeting for the initial Management Analysis and Services review of applications in response to Office, CDC, pursuant to Public Law 92– Funding Opportunity Announcement 463. (FOA) DP17–001, Community Matters for Discussion: The meeting Characteristics Associated with will include the initial review, VerDate Sep<11>2014 16:21 Apr 03, 2017 Jkt 241001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1


Document Created: 2017-04-03 23:53:10
Document Modified: 2017-04-03 23:53:10
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
FR Citation82 FR 16403 
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