82 FR 26931 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 111 (June 12, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 111 (June 12, 2017)
| Page Range | 26931-26933 | |
| FR Document | 2017-12060 |
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)] [Notices] [Pages 26931-26933] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12060] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-17BZ] 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 [[Page 26932]] 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 [email protected]. 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 Project PrIDE (PrEP Implementation, Data to Care & Evaluation)-- New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Approximately 50,000 people in the United States are newly infected with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) remain the US population most heavily affected by HIV infection. Among MSM, those who are black and Hispanic comprise 58% of all new infections. To address the burden of HIV in this population, high impact HIV prevention approaches should be implemented by state, local, and territorial health departments to reduce new HIV infections among MSM of color, and to improve outcomes along the HIV continuum of care for MSM of color living with HIV. Antiretroviral (ARV) medications for pre-exposure prophylaxis (PrEP) can be used for HIV prevention by MSM at substantial risk for HIV acquisition or by those with a possible HIV exposure in the past 72 hours post-exposure prophylaxis (nPEP). The daily use of co-formulated tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada) for PrEP has been proven to significantly reduce the risk of HIV acquisition among sexually active MSM. In July 2012, the US Food and Drug Administration approved an HIV prevention indication for Truvada, and in May 2014 CDC published clinical practice guidelines for provision of PrEP. Given the high incidence of HIV among MSM of color, those who are sexually active are considered at risk for HIV acquisition and thus could benefit from prevention services such as routine and frequent HIV screening with lab-based 4th generation HIV tests, routine screening for STDs, assessment of PrEP eligibility, provision of PrEP (if at substantial risk for HIV acquisition), provision of nPEP (if a possible HIV exposure occurred in the past 72 hours), and/or other risk reduction interventions. Among people living with HIV (PLWH), ARV treatment can suppress HIV viral load, which both improves health outcomes of individuals and reduces the risk of HIV transmission. Two studies, one that demonstrated the effectiveness of ARV treatment in preventing HIV transmission, and one that demonstrated improved health outcomes for individuals whose ARV treatment was initiated immediately, have led to increased public health focus on interventions and strategies designed to initiate ARV treatment, link, retain, and re-engage PLWH in HIV care, and to provide support for adherence to ARV medications. The purpose of the project is to implement PrEP demonstration projects. Health departments that are funded under this cooperative agreement will be required to prioritize their services to MSM and transgender persons at high risk of HIV infection, particularly persons of color. PrEP services may also be provided to HIV-negative persons at substantial risk for HIV who are not MSM or transgender. Additionally, Data to Care services may be provided to persons diagnosed with HIV infection and out of care, those who are in care but not virally suppressed, or those who have ongoing risk behavior who are not MSM or transgender. The goals of PrIDE are consistent with the long-term goals of the National HIV/AIDS Strategy (NHAS) including reducing HIV incidence, increasing access to HIV care and optimizing health outcomes, and reducing HIV-related health disparities. To evaluate the impact of PrIDE in the 12 jurisdictions, data will be collected from both existing CDC data sources and through new data collection activities. CDC HIV program grantees will collect, enter or upload, and report agency-identifying information, budget data, information on the HIV prevention and care services, and client demographic characteristics. The total annual burden hours are 1,104. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Clients............................... Data Elements........... 2,400 1 25/60 Health Departments.................... Data Management Upload.. 12 2 20/60 Health Departments.................... Performance Progress 12 1 8 Report. ---------------------------------------------------------------------------------------------------------------- [[Page 26933]] 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. 2017-12060 Filed 6-9-17; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 26931
Colombia’s Instituto Nacional de outcomes associated with ZIKV consecutive tests for ZIKV or the
Salud (INS) began surveillance for ZIKV infection; (4) Assess modifiers of the pregnancy ends. At all study visits, male
in 2015, reporting the first risk for adverse outcomes among partners will complete visit-specific
autochthonous transmission in October pregnant women and their infants questionnaires and provide samples for
2015 in the north of the country. As of following ZIKV infection. This includes laboratory testing.
October 2016, Colombia has reported investigating associations with All newborns of mothers participating
over 105,000 suspected ZIKV cases, gestational age at infection, presence of
in the study will be followed every
with over 19,000 of them among ZIKV symptoms, extended viremia,
other week from birth to 6 months of
pregnant women. With a causal link mode of transmission, prior infections
age. At all visits, infants will receive
established between ZIKV infection in or immunizations, and co-infections.
The project aims to enroll national recommended clinical care (at
pregnancy and microcephaly, there is an
urgent need to understand: How ZIKV approximately 5,000 women, 1,250 male birth and clinic visits at 1, 2, and 6
transmission can be prevented; the full partners, and 4,500 newborns. Pregnant months), provide samples for laboratory
spectrum of adverse maternal, fetal, and women will be recruited in the first testing, and mothers will complete
infant health outcomes associated with trimester of pregnancy for study study-specific questionnaires about
ZIKV infection; and risk factors for enrollment, followed by assessments infant ZIKV symptoms and
occurrence of these outcomes. To during pregnancy (every other week developmental milestones. During
answer these questions, INS and the until 32 weeks gestation and monthly follow-up, infants will also have cranial
U.S. Centers for Disease Control and thereafter), and within 10 days ultrasounds, their head circumference
Prevention (CDC) will follow 5,000 postpartum. At all visits, participants measured, and hearing and vision tests.
women enrolled in the first trimester of will complete visit-specific For mothers and their infants, relevant
pregnancy, their male partners, and questionnaires. In addition to the information collected as part of clinical
their infants, in various cities in questionnaires, at all pregnancy and care will be abstracted from medical
Colombia where ZIKV transmission is delivery visits, participants will receive records. Study results will be used to
currently ongoing. Colombian national recommended guide recommendations made by both
The primary study objectives are to: clinical care and provide samples for INS and CDC to prevent ZIKV infection;
(1) Describe the sociodemographic and laboratory testing. to improve counseling of patients about
clinical characteristics of the study Male partners will be recruited risks to themselves, their pregnancies,
population; (2) Identify risk factors for around the time of the pregnant their partners, and their infants; and to
ZIKV infection in pregnant women and partners’ study enrollment, followed by help agencies prepare to provide
their infants. These include behaviors monthly visits until his pregnant services to affected children and
such as use of mosquito-bite prevention partner reaches the third trimester families. Participation in this study is
measures or condoms, and factors (approximately 27 weeks gestation). If voluntary. The estimated number of
associated with maternal-to-child the male partner contracts ZIKV during annual Burden Hours are 20,548 and
transmission; (3) Assess the risk for this time, visits will occur every other there are no costs to participants other
adverse maternal, fetal, and infant week until the partner has two negative than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden
Respondents Form name responses per
respondents per response
respondent (in hours)
Pregnant women ............................................. Pregnant women eligibility questionnaire ...... 3,125 1 5/60
Pregnant women enrollment questionnaire ... 2,500 1 35/60
Adult symptom questionnaire ......................... 2,500 15 10/60
Pregnant women follow-up questionnaire ...... 2,500 8 15/60
Infant symptoms questionnaire ...................... 2,250 14 10/60
Infant Ages and Stages Questionnaire: 2 2,250 1 15/60
Month.
Infant Ages and Stages Questionnaire: 6 2,250 1 15/60
Month.
Male partners .................................................. Male partner eligibility questionnaire ............. 2,500 1 5/60
Male enrollment questionnaire ....................... 625 1 25/60
Adult symptom questionnaire ......................... 625 7 10/60
Leroy A. Richardson, DEPARTMENT OF HEALTH AND following information collection request
Chief, Information Collection Review Office, HUMAN SERVICES to the Office of Management and Budget
Office of Scientific Integrity, Office of the (OMB) for review and approval in
Associate Director for Science, Office of the Centers for Disease Control and accordance with the Paperwork
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Director, Centers for Disease Control and Prevention Reduction Act of 1995. The notice for
Prevention. the proposed information collection is
[FR Doc. 2017–12059 Filed 6–9–17; 8:45 am] [30Day–17–17BZ] published to obtain comments from the
BILLING CODE 4163–18–P public and affected agencies.
Agency Forms Undergoing Paperwork
Reduction Act Review Written comments and suggestions
from the public and affected agencies
The Centers for Disease Control and concerning the proposed collection of
Prevention (CDC) has submitted the information are encouraged. Your
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![Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 26933
Leroy A. Richardson, prevention and control; (2) strategies for DEPARTMENT OF HEALTH AND
Chief, Information Collection Review Office, surveillance, prevention, and control of HUMAN SERVICES
Office of Scientific Integrity, Office of the infections, antimicrobial resistance, and
Associate Director for Science, Office of the related events in settings where Centers for Disease Control and
Director, Centers for Disease Control and Prevention
Prevention.
healthcare is provided; and (3) periodic
updating of CDC guidelines and other
[FR Doc. 2017–12060 Filed 6–9–17; 8:45 am] Disease, Disability, and Injury
policy statements regarding prevention
BILLING CODE 4163–18–P
of healthcare-associated infections and Prevention and Control Special
healthcare-related conditions. Emphasis Panel (SEP): Secondary
Review
DEPARTMENT OF HEALTH AND Matters for Discussion: The agenda
HUMAN SERVICES will include updates on CDC’s activities In accordance with Section 10(a)(2) of
for prevention of healthcare associated the Federal Advisory Committee Act
Centers for Disease Control and infections (HAIs), an update on the
Prevention (Pub. L. 92–463), the Centers for Disease
Division of Healthcare Quality Control and Prevention (CDC)
Healthcare Infection Control Practices Promotion’s (DHQP) modeling announces a meeting for the secondary
Advisory Committee (HICPAC) activities, updates on the Guideline for review of applications in response to
Prevention of Infection in Neonatal Funding Opportunity Announcements
In accordance with section 10(a)(2) of Intensive Care Unit (NICU) Patients and (FOAs), CE17–003, Research Grants for
the Federal Advisory Committee Act the Guideline for Prevention of Infection Preventing Violence and Violence
(Pub. L. 92–463), the Centers for Disease in Healthcare Personnel, and updates Related Injury (R01); and PHS 2016–02
Control and Prevention (CDC), National from the following HICPAC workgroups:
Center for Emerging and Zoonotic Omnibus Solicitation of the NIH, CDC
The workgroup on antibiotic FDA, and ACF for Small Business
Infectious Diseases (NCEZID) announces stewardship principles for inclusion
a meeting of the aforementioned Innovation Research Grant Applications
into clinical practice guidelines, the (Parent SBIR [R43/R44]).
committee: workgroup on updating the CDC
Times and Dates: Time and Date: 8:00 a.m.–5:00 p.m.,
recommendation categorization scheme,
9:00 a.m.–5:00 p.m., EDT, July 13, 2017 EDT, July 18, 2017 (Closed).
the workgroup on developing CDC
9:00 a.m.–12:00 p.m., EDT, July 14, 2017 recommendations for products and Place: Teleconference.
Place: Centers for Disease Control and practices, and the National Healthcare Status: The meeting will be closed to
Prevention, Global Communications Safety Network (NHSN) Surveillance the public in accordance with
Center, Building 19, Auditorium B, 1600 Workgroup. provisions set forth in Section
Clifton Road NE., Atlanta, Georgia, 552b(c)(4) and (6), Title 5 U.S.C., and
30329. Agenda items are subject to change as
priorities dictate. the Determination of the Director,
Status: Open to the public, limited
Contact Person for More Information: Management Analysis and Services
only by the space available. Time will
Erin Stone, M.A., HICPAC, Division of Office, CDC, pursuant to Public Law 92–
be available for public comment. The
public is welcome to submit written Healthcare Quality Promotion, NCEZID, 463.
comments in advance of the meeting. CDC, l600 Clifton Road NE., Mailstop Matters for Discussion: The meeting
Comments should be submitted in A–07, Atlanta, Georgia 30329, will include the secondary review,
writing by email to the contact person Telephone (404) 639–4045. Email: discussion, and evaluation of
listed below. The deadline for receipt is hicpac@cdc.gov. applications received in response to
June 30, 2017. All requests must contain FOAs ‘‘Research Grants for Preventing
The Director, Management Analysis
the name, address, and organizational Violence and Violence Related Injury
affiliation of the speaker, as well as the and Services Office, has been delegated
the authority to sign Federal Register (R01)’’, CE17–003; and ‘‘PHS 2016–02
topic being addressed. Written Omnibus Solicitation of the NIH, CDC
comments should not exceed one single- notices pertaining to announcements of
meetings and other committee FDA, and ACF for Small Business
spaced typed page in length and Innovation Research Grant Applications
delivered in 3 minutes or less. Members management activities, for both the
Centers for Disease Control and (Parent SBIR [R43/R44])’’.
of the public who wish to provide
public comments should plan to attend Prevention and the Agency for Toxic Contact Person for More Information:
the public comment session at the start Substances and Disease Registry. Gwendolyn H. Cattledge, Ph.D.,
time listed. Please note that the public M.S.E.H., Deputy Associate Director for
Elaine L. Baker, Science, National Center for Injury
comment period may end before the
time indicated on the agenda, following Director, Management Analysis and Services Prevention and Control, CDC, 4770
Office, Centers for Disease Control and Buford Highway NE., Mailstop F–63,
the last call for comments. Written
Prevention. Atlanta, Georgia 30341, Telephone (770)
comments received in advance of the
[FR Doc. 2017–12122 Filed 6–9–17; 8:45 am] 488–1430.
meeting will be included in the official
record of the meeting. BILLING CODE 4163–18–P
The Director, Management Analysis
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Purpose: The Committee is charged and Services Office, has been delegated
with providing advice and guidance to the authority to sign Federal Register
the Director, Division of Healthcare notices pertaining to announcements of
Quality Promotion (DHQP), the Director, meetings and other committee
National Center for Emerging and management activities, for both the
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
the Director, CDC, the Secretary, Health
and Human Services regarding (1) the
practice of healthcare infection
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Document Created: 2017-06-10 01:40:26
Document Modified: 2017-06-10 01:40:26
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| FR Citation | 82 FR 26931 |
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