83_FR_45617 83 FR 45443 - Agency Forms Undergoing Paperwork Reduction Act Review

83 FR 45443 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 174 (September 7, 2018)

Page Range45443-45444
FR Document2018-19383

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 22, 2018 for public comment.

Federal Register, Volume 83 Issue 174 (Friday, September 7, 2018)
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45443-45444]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19383]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-1102]


Agency Forms Undergoing Paperwork Reduction Act Review

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period; withdrawal.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) announces the withdrawal 
of the notice published under the same title on August 22, 2018 for 
public comment.

DATES: Applicable September 7, 2018.

FOR FURTHER INFORMATION CONTACT: Information Collection Review Office,

[[Page 45444]]

Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION: On August 22, 2018 CDC published a notice in 
the Federal Register titled ``Information Collection for Tuberculosis 
Data from Panel Physicians'' (Vol. 83, No. 163 Docket No. CDC-2018-
0049, Pages 42502-542503). This notice was published inadvertently. The 
notice is being withdrawn immediately for public comment.

Jeffrey M. Zirger,
Acting 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. 2018-19383 Filed 9-6-18; 8:45 am]
 BILLING CODE 4163-18-P



                                                                           Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices                                                                     45443

                                               are to respond, including, through the                         bisexual, and other men who have sex                                   understand the HIV risk behavior
                                               use of appropriate automated,                                  with men (MSM) than any other risk                                     context, attitudes towards PrEP, health
                                               electronic, mechanical, or other                               group in the U.S. Approximately half of                                seeking behavior, and acceptability of
                                               technological collection techniques or                         all diagnosed HIV infections are among                                 new modes of PrEP delivery (that differ
                                               other forms of information technology,                         gay, bisexual, and other MSM. The                                      from current recommendation of daily
                                               e.g., permitting electronic submission of                      FDA-approved PrEP regimen, daily                                       PrEP and that are in development or
                                               responses; and                                                 Tenofovir/emtricitabine (aka Truvada®),                                discussion) and emerging biomedical
                                                 (e) Assess information collection                            has shown greater than 90% efficacy in                                 HIV prevention options.
                                               costs.                                                         reducing HIV infections among MSM                                         The purpose of this research is to
                                                 To request additional information on                         when taken in accordance with its                                      explore decisions, barriers, and
                                               the proposed project or to obtain a copy                       prescribed daily schedule. In 2014, CDC                                facilitators about PrEP use among MSM:
                                               of the information collection plan and                         published clinical practice guidelines                                 (1) Who were offered PrEP but refused
                                               instruments, call (404) 639–7570 or                            for the use of PrEP in high-risk                                       it; (2) who were interested in or started
                                               send an email to omb@cdc.gov. Direct                           populations, and began national                                        a PrEP regimen but did not follow
                                               written comments and/or suggestions                            promotion of PrEP as an effective HIV                                  through; and (3) who are eligible for
                                               regarding the items contained in this                          prevention strategy for MSM. While                                     PrEP per CDC guidelines (report
                                               notice to the Attention: CDC Desk                              hailed as an HIV-prevention ‘‘game-                                    condomless anal sex within last three
                                               Officer, Office of Management and                              changer,’’ in reality PrEP uptake has                                  months) but not currently on PrEP.
                                               Budget, 725 17th Street NW,                                    been slow. Some studies report a wide
                                                                                                              range in the percentages of MSM (28–                                      This study will provide insight on
                                               Washington, DC 20503 or by fax to (202)
                                                                                                              81%) interested in PrEP. In addition,                                  individual and community level PrEP-
                                               395–5806. Provide written comments
                                                                                                              other studies indicate that specific cities                            related decision-making, and identify
                                               within 30 days of notice publication.
                                                                                                              have alarmingly low rates of PrEP                                      barriers and facilitators to successful
                                               Proposed Project                                               uptake (for example, the estimate for                                  PrEP initiation and PrEP acceptability.
                                                 Understanding Decisions and Barriers                         Atlanta is 2%). Moreover, recent survey                                Findings will improve programming, in
                                               about PrEP Use and Uptake Among Men                            findings have shown that less than 1 in                                line with the CDC Division of HIV/AIDS
                                               Who Have Sex With Men—New—                                     10 MSM on PrEP are adherent to their                                   Prevention goal of high-impact
                                               National Center for HIV/AIDS, Viral                            PrEP regimen; adherence is necessary to                                prevention to reduce HIV infections in
                                               Hepatitis, STD, and TB Prevention,                             optimize efficacy.                                                     the U.S. Findings will assist the CDC
                                               Centers for Disease Control and                                   In order to develop effective programs                              and frontline public health programs in
                                               Prevention (CDC).                                              that increase PrEP uptake among MSM                                    identifying and designing programs and
                                                                                                              at greatest risk for HIV, studies are                                  intervention approaches that encourage,
                                               Background and Brief Description                               needed to better understand the                                        support, and maintain appropriate PrEP
                                                 This project involves original,                              decisions men make about their HIV                                     uptake among eligible MSM and
                                               formative research toward improving                            prevention needs. Qualitative methods                                  anticipate future HIV prevention needs,
                                               the uptake and adherence necessary to                          will be used to explore in-depth the                                   including anticipated changes in PrEP
                                               achieve efficacious levels of protection                       ‘‘Whys’’ and ‘‘How’s’’ of MSM’s                                        delivery.
                                               offered by pre-exposure prophylaxis                            decisions to refuse or use PrEP, and                                      The total annual burden hours are
                                               (PrEP) among the most highly affected                          barriers and challenges to successfully                                335. There are no other costs to the
                                               population. HIV incidence and                                  undertake a PrEP medication regimen.                                   respondents other than their time to
                                               prevalence are higher among gay,                               Quantitative methods will be used to                                   participate.

                                                                                                             ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                       Average
                                                                                                                                                                                                       Number of
                                                         Type of                                                                                                                     Number of                       burden per
                                                                                                                        Form name                                                                    responses per
                                                       respondents                                                                                                                  respondents                       response
                                                                                                                                                                                                       respondent     (in hours)

                                               General   Public—Adults   .....   Screener .......................................................................................           600                  1           5/60
                                               General   Public—Adults   .....   Contact Information Form ............................................................                      300                  1           1/60
                                               General   Public—Adults   .....   In-Depth Interview Guide .............................................................                      60                  1          45/60
                                               General   Public—Adults   .....   Focus Group Moderator Guide ....................................................                            60                  1              1
                                               General   Public—Adults   .....   Eligibility verification (verification of continuing eligibility) ............                             300                  1           5/60
                                               General   Public—Adults   .....   Structured response self-administered behavioral assessment ..                                             300                  1          30/60



                                               Jeffrey M. Zirger,                                             DEPARTMENT OF HEALTH AND                                               ACTION:Notice with comment period;
                                               Acting Chief, Information Collection Review                    HUMAN SERVICES                                                         withdrawal.
                                               Office, Office of Scientific Integrity, Office
                                               of the Associate Director for Science, Office                  Centers for Disease Control and                                        SUMMARY:   The Centers for Disease
                                               of the Director, Centers for Disease Control                   Prevention                                                             Control and Prevention (CDC) in the
                                               and Prevention.                                                                                                                       Department of Health and Human
daltland on DSKBBV9HB2PROD with NOTICES




                                               [FR Doc. 2018–19378 Filed 9–6–18; 8:45 am]
                                                                                                              [60Day–18–1102]                                                        Services (HHS) announces the
                                                                                                                                                                                     withdrawal of the notice published
                                               BILLING CODE 4163–18–P                                         Agency Forms Undergoing Paperwork                                      under the same title on August 22, 2018
                                                                                                              Reduction Act Review                                                   for public comment.
                                                                                                              AGENCY: Centers for Disease Control and                                DATES: Applicable September 7, 2018.
                                                                                                              Prevention (CDC), Department of Health                                 FOR FURTHER INFORMATION CONTACT:
                                                                                                              and Human Services (HHS).                                              Information Collection Review Office,


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                                               45444                       Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices

                                               Centers for Disease Control and                         ADDRESSES:    You may submit comments,                are to respond, including through the
                                               Prevention, 1600 Clifton Road NE, MS–                   identified by Docket No. CDC–2018–                    use of appropriate automated,
                                               D74, Atlanta, Georgia 30329; phone:                     0042 by any of the following methods:                 electronic, mechanical, or other
                                               404–639–7570; email: omb@cdc.gov.                          • Federal eRulemaking Portal:                      technological collection techniques or
                                               SUPPLEMENTARY INFORMATION: On August                    Regulations.gov. Follow the instructions              other forms of information technology,
                                               22, 2018 CDC published a notice in the                  for submitting comments.                              e.g., permitting electronic submissions
                                               Federal Register titled ‘‘Information                      • Mail: Jeffrey M. Zirger, Information             of responses.
                                               Collection for Tuberculosis Data from                   Collection Review Office, Centers for                   5. Assess information collection costs.
                                               Panel Physicians’’ (Vol. 83, No. 163                    Disease Control and Prevention, 1600
                                                                                                       Clifton Road NE, MS–D74, Atlanta,                     Proposed Project
                                               Docket No. CDC–2018–0049, Pages
                                                                                                       Georgia 30329.                                          National Healthcare Safety Network
                                               42502–542503). This notice was
                                                                                                          Instructions: All submissions received             (NHSN)—Revision—National Center for
                                               published inadvertently. The notice is
                                                                                                       must include the agency name and                      Emerging and Zoonotic Infectious
                                               being withdrawn immediately for public                                                                        Diseases (NCEZID), Centers for Disease
                                                                                                       Docket Number. CDC will post, without
                                               comment.                                                                                                      Control and Prevention (CDC).
                                                                                                       change, all relevant comments to
                                               Jeffrey M. Zirger,                                      Regulations.gov.
                                                                                                                                                             Background and Brief Description
                                               Acting Chief, Information Collection Review                Please note: Submit all comments
                                               Office, Office of Scientific Integrity, Office          through the Federal eRulemaking portal                   NHSN is a public health surveillance
                                               of the Associate Director for Science, Office           (regulations.gov) or by U.S. mail to the              system that collects, analyzes, reports,
                                               of the Director, Centers for Disease Control            address listed above.                                 and makes available data for
                                               and Prevention.                                         FOR FURTHER INFORMATION CONTACT: To                   monitoring, measuring, and responding
                                               [FR Doc. 2018–19383 Filed 9–6–18; 8:45 am]              request more information on the                       to healthcare associated infections
                                               BILLING CODE 4163–18–P                                  proposed project or to obtain a copy of               (HAIs), antimicrobial use and resistance,
                                                                                                       the information collection plan and                   blood transfusion safety events, and the
                                                                                                       instruments, contact Leroy A.                         extent to which healthcare facilities
                                               DEPARTMENT OF HEALTH AND                                Richardson, Information Collection                    adhere to infection prevention practices
                                               HUMAN SERVICES                                          Review Office, Centers for Disease                    and antimicrobial stewardship. The data
                                                                                                       Control and Prevention, 1600 Clifton                  collected will be used to inform and
                                               Centers for Disease Control and                         Road NE, MS–D74, Atlanta, Georgia                     detect changes in the epidemiology of
                                               Prevention                                              30329; phone: 404–639–7570; Email:                    adverse events resulting from new and
                                               [60Day–18–0666; Docket No. CDC–2018–                    omb@cdc.gov.                                          current medical therapies and changing
                                               0042]                                                   SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                             risks. NHSN is comprised of six
                                                                                                       Paperwork Reduction Act of 1995 (PRA)                 components: Patient Safety, Healthcare
                                               Proposed Data Collection Submitted                      (44 U.S.C. 3501–3520), Federal agencies               Personnel Safety, Biovigilance, Long-
                                               for Public Comment and                                  must obtain approval from the Office of               Term Care Facility, Outpatient
                                               Recommendations                                         Management and Budget (OMB) for each                  Procedure, and Dialysis.
                                                                                                       collection of information they conduct                   Changes were made to 33 data
                                               AGENCY: Centers for Disease Control and                                                                       collection facility surveys with this new
                                               Prevention (CDC), Department of Health                  or sponsor. In addition, the PRA also
                                                                                                       requires Federal agencies to provide a                ICR. CDC revised three annual facility
                                               and Human Services (HHS).                                                                                     surveys for the Patient Safety
                                                                                                       60-day notice in the Federal Register
                                               ACTION: Notice with comment period.                                                                           component for Hospitals, Long-Term
                                                                                                       concerning each proposed collection of
                                                                                                       information, including each new                       Acute Care Facilities, and Inpatient
                                               SUMMARY:   The Centers for Disease                                                                            Rehabilitation Facilities. CDC’s
                                               Control and Prevention (CDC), as part of                proposed collection, each proposed
                                                                                                       extension of existing collection of                   revisions clarify the reporting
                                               its continuing effort to reduce public                                                                        requirements for the data collected on
                                               burden and maximize the utility of                      information, and each reinstatement of
                                                                                                       previously approved information                       fungal testing, facility locations, and
                                               government information, invites the                                                                           laboratory testing locations.
                                               general public and other Federal                        collection before submitting the
                                                                                                       collection to the OMB for approval. To                Additionally, corresponding response
                                               agencies the opportunity to comment on                                                                        options for these questions have been
                                               a proposed and/or continuing                            comply with this requirement, we are
                                                                                                       publishing this notice of a proposed                  revised to include updated testing
                                               information collection, as required by                                                                        methods used by facilities to capture
                                               the Paperwork Reduction Act of 1995.                    data collection as described below.
                                                                                                          The OMB is particularly interested in              current HAI specific data specification
                                               This notice invites comment on a                                                                              requirements for NHSN. New required
                                               proposed information collection project                 comments that will help:
                                                                                                          1. Evaluate whether the proposed                   questions have been added to all Patient
                                               titled National Healthcare Safety                                                                             Safety component surveys. The new
                                               Network (NHSN). NHSN is a public                        collection of information is necessary
                                                                                                       for the proper performance of the                     questions are designed to provide data
                                               health surveillance system that collects,                                                                     on surveillance processes, policies, and
                                               analyzes, reports, and makes available                  functions of the agency, including
                                                                                                       whether the information will have                     standards that are used by reporting
                                               data for monitoring, measuring, and                                                                           facilities to ensure that when an event
                                               responding to healthcare associated                     practical utility;
                                                                                                          2. Evaluate the accuracy of the                    is detected, the facility has the
                                               infections (HAIs), antimicrobial use and                                                                      appropriate mechanism to conduct
                                                                                                       agency’s estimate of the burden of the
                                               resistance, blood transfusion safety                                                                          complete reporting. The Hospital
                                                                                                       proposed collection of information,
daltland on DSKBBV9HB2PROD with NOTICES




                                               events, and the extent to which                                                                               Annual Survey added new required
                                                                                                       including the validity of the
                                               healthcare facilities adhere to infection                                                                     questions to provide data about neonatal
                                                                                                       methodology and assumptions used;
                                               prevention practices and antimicrobial                                                                        antimicrobial stewardship practices
                                                                                                          3. Enhance the quality, utility, and
                                               stewardship.                                                                                                  because the focus of stewardship efforts
                                                                                                       clarity of the information to be
                                               DATES:CDC must receive written                          collected; and                                        in neonatology differ from the focus in
                                               comments on or before November 6,                          4. Minimize the burden of the                      adult and pediatric practice. Questions
                                               2018.                                                   collection of information on those who                were removed and replaced on all three


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Document Created: 2018-09-07 00:15:23
Document Modified: 2018-09-07 00:15:23
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
ActionNotice with comment period; withdrawal.
DatesApplicable September 7, 2018.
ContactInformation Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; email: [email protected]
FR Citation83 FR 45443 

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