Proposed Data Collection Submitted for Public Comment and Recommendations, 44792-44794 [2017-20511]

Download as PDF 44792 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices updated estimate (based on historical information) of state nonmember banks and state savings associations engaged in consumer leasing. In particular, the number of respondents has decreased while the hours per response remain the same. 2. Title: Covered Financial Company Asset Purchaser Eligibility Certification. OMB Number: 3064–0194. Form Number: Covered Financial Company Asset Sales Purchaser Eligibility Certification—7300/10. Affected Public: Any individual or entity that is a potential purchaser of assets from (1) the FDIC as receiver for a Covered Financial Company (‘‘CFC’’); or (2) a bridge financial company (‘‘BFC’’) which requires the approval of the FDIC, as receiver for the predecessor CFC and as the sole shareholder of the BFC (e.g., the BFC’s sale of a significant business line). Burden Estimate: Type of burden Estimated number of respondents Estimated number of responses Estimated time per response (minutes) Frequency of response Total annual estimated burden (hours) Covered Financial Company Asset Sales Purchaser Eligibility Certification. Reporting ............................. 10 1 30 Annual ......... 5 Total Hourly Burden ...... .............................................. ........................ ........................ ........................ ..................... 5 General Description of Collection: Assets held by the FDIC in the course of liquidating any covered financial company must not be sold to persons who contributed to the demise of a covered financial company in specified ways (e.g., individuals who profited or engaged in wrongdoing at the expense of the failed institution, or seriously mismanaged the failed institution). 12 CFR part 380 requires prospective purchasers to complete and submit a Purchaser Eligibility Certification (‘‘PEC’’) to the FDIC. The PEC is a selfcertification by a prospective purchaser that it does not fall into any of the categories of individuals or entities that are prohibited by statute or regulation from purchasing the assets of covered financial companies. The PEC will be required in connection with the sale of assets by the FDIC, as receiver for a CFC, or the sale of assets by a BFC which requires the approval of the FDIC, as receiver for the predecessor CFC and as the sole shareholder of the BFC. There is no change in the method or substance of the collection. The number of respondents and the hours per response remain the same. Request for Comment Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC’s functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information VerDate Sep<11>2014 18:28 Sep 25, 2017 Jkt 241001 technology. All comments will become a matter of public record. Dated at Washington, DC, this 20th day of September 2017. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary. [FR Doc. 2017–20593 Filed 9–25–17; 8:45 am] BILLING CODE 6714–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–17–1080; Docket No. CDC 2017– 0078] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on HIV Outpatient Study (HOPS). DATES: Written comments must be received on or before November 27, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC–2017– 0078 by any of the following methods: SUMMARY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. • Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above. To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, 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: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information FOR FURTHER INFORMATION CONTACT: E:\FR\FM\26SEN1.SGM 26SEN1 44793 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project HIV Outpatient Study (HOPS) (OMB Control Number 0920–1080, Expiration, 8/31/2018)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CDC requests a three-year approval and a revision to the HIV Outpatient Study data collection activity. The HIV Outpatient Study (HOPS) is a prospective longitudinal obesity, diabetes) and antiretroviral drug resistance. Researchers will collect data through medical record abstraction by trained abstractors and by telephone or Internet based, computer-assisted interviews at eight funded study sites in six U.S. cities. Collection of data abstracted from patient medical records provides data in five general categories: Demographics and risk behaviors for HIV infection; symptoms; diagnosed conditions (definitive and presumptive); medications prescribed (including dose, duration, and reasons for stopping); all laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma HIV–RNA determinations, and genotype, phenotype, and trophile results. Researchers will acquire data on visit frequency, AIDS, and death from the clinic chart. Data collected using a brief Telephone Audio-Computer Assisted Self-Interview (T–ACASI) survey or an identical Web-based Audio-Computer Assisted SelfInterview (ACASI) include: Age, sex at birth, use of alcohol and drugs, cigarette smoking, adherence to antiretroviral medications, types of sexual intercourse, condom use, and disclosure of HIV status to partners. We anticipate the annual recruitment of 450 new HOPS study participants into the HOPS from a pool of HIVinfected individuals currently in HIVcare at nine clinics (50 patients per site). Researchers will approach patients during one of the patients’ routine clinic visits to participate in the HOPS. Researchers will give patients interested in participating in the HOPS detailed information about the nature of the study and provide them with a written informed consent form that the patient must complete prior to enrollment. Annually, the researchers will add the 450 newly enrolled participants to the database of existing participants. Researchers will conduct medical record abstractions and will not impose direct burden on HOPS study participants. Participation of respondents is voluntary. There is no cost to the respondents other than their time. cohort of HIV-infected outpatients at eight well-established private HIV care practices and university-based U.S. clinics, in Tampa, Florida; Washington, DC; Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and Philadelphia, Pennsylvania. Researchers abstract clinical data on an ongoing basis from the medical records of adult HIV-infected HOPS study participants, who also complete an optional telephone/Web-based behavioral assessment as part of their annual clinic visit, which on average takes about seven minutes. Before enrolling in this study, all potential study participants will undergo an informed consent process (including signing of a written informed consent), which is estimated to take 15 minutes. The revisions consist of adding 12 additional survey questions to assess additional risk behaviors that may affect the long-term care and treatment of HIV positive patients participating in the HIV Outpatient Study. Based on review of the current survey response items and the average completion time, these new questions will not pose additional burden on participants. The core areas of HOPS research extending through the present HIV treatment era include: (i) Monitoring death rates and causes of death; (ii) characterizing the optimal patient management strategies to reduce HIV related morbidity and mortality (e.g., effectiveness of antiretroviral therapies and other clinical interventions); (iii) monitoring of sexual and drug use behaviors to inform Prevention with Positives; and (iv) investigating disparities in the HIV care continuum by various demographic factors. In recent years, the HOPS has been instrumental in bringing attention to emerging issues in chronic HIV infection with actionable opportunities for prevention, including cardiovascular disease, fragility fractures, renal and hepatic disease, and cancers. The HOPS remains an important source for multiyear trend data concerning conditions and behaviors for which data are not readily available elsewhere, to include: Rates of opportunistic illnesses, rates of comorbid conditions (e.g., hypertension, ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Type of respondent Form name HOPS study Patients ........................ HOPS Study Patients ....................... Behavioral survey ............................. Consent form .................................... 2,500 450 1 1 7/60 15/60 292 113 Total ........................................... ........................................................... ........................ ........................ ........................ 405 VerDate Sep<11>2014 18:28 Sep 25, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1 44794 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / 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. 2017–20511 Filed 9–25–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–17–17NW] 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. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on April 27, 2017 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. The purpose of this notice is to allow an additional 30 days for public comments. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. The Office of Management and Budget is particularly interested in comments that: (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. VerDate Sep<11>2014 18:28 Sep 25, 2017 Jkt 241001 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. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project A Novel Framework for Structuring Industry-Tuned Public-Private Partnerships and Economic Incentives for U.S. Health Emergency Preparedness and Response—New—Office of Public Health Preparedness and Response (OPHPR), Centers for Disease Control and Prevention (CDC). Background and Brief Description Despite the important role of publicprivate partnerships in supporting the US’s public health preparedness and response mission, many partnership efforts are not successful due to poorly aligned incentives or lack of awareness of external market factors. There is little research or information on private sector incentive structures and partnership opportunities and barriers specific to public health preparedness and response. This study will evaluate the effectiveness of public-private partnership incentives from the perspective of private sector industries within the public health preparedness and response space. Study activities include the following: (1) Identification of public-private partnership incentives and target industries for public health preparedness and response; (2) interviews with industry leaders (in person or via telephone) to identify related public health emergency preparedness activities and partnership opportunities and barriers; (3) survey of private sector organization managers using on-line technology (Qualtrics) on key issues and attractiveness of partnership opportunities and incentives; and (4) framework development to identify partnership target organizations, opportunities, and incentives to promote public health emergency preparedness capabilities. CDC proposes to collect information from the private industry leaders in the public health preparedness and response space to accomplish this goal. The information collection project is composed of two parts: (1) Interviews and (2) an on-line general survey. The PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 targeted interviews will seek respondents in the following eight sectors: Pharmaceutical/life sciences (n=8), health IT/mobile (n=8), retailers/ distributors (n=6), academia/research organization (n=6), hospital/healthcare provider (n=5), health insurance (n=4), logistics/transportation (n=4), and charitable organization/foundation (n=4). The interview questions and the information collected will vary significantly across the different sectors. The survey portion of the information collection consists of a larger survey administered to 200 individuals to reach a total sample population of 100 (assuming a 50% response rate). CDC will conduct the interviews and administer the survey only one time to each individual respondent. CDC plans to conduct interviews and surveys within six months after OMB approval. Members of the research team will conduct the interviews. CDC will administer the surveys using the secure online software Qualtrics, and respondents will receive an email with a unique link that will direct them to the Qualtrics survey platform. The research team will then transfer data to CDC’s preferred Secure File Transfer Protocol (SFTP) client for secure storage and access. After this transfer, CDC will destroy all copies of the data that reside outside of the SFTP. Only the research team will have access to the interview transcripts and survey responses that will link responses to personally identifiable information. Researchers will use locked file cabinets to store securely, any printed or hand-written documents containing personal identifiable information. Once scanned or otherwise transferred into electronic files (which will also be transferred to the SFTP client), researchers will appropriately destroy the information. Only the research team will have access to the SFTP, which will require the user to enter a host address, username, password and port number. Any information removed from the SFTP client to be shared with outside parties will be presented in aggregated and de-identified form, unless otherwise compelled by law. CDC will retain and destroy all records in accordance with the applicable CDC Records Control Schedule. OPHPR is requesting an approval period of one year to collect this information. There is no cost to respondents other than the time to participate. The total estimated annual burden hours is 70 hours. A summary of annualized burden hours is below. E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44792-44794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20511]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-1080; Docket No. CDC 2017-0078]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

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

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on HIV Outpatient 
Study (HOPS).

DATES: Written comments must be received on or before November 27, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0078 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, 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: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information

[[Page 44793]]

collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    HIV Outpatient Study (HOPS) (OMB Control Number 0920-1080, 
Expiration, 8/31/2018)--Revision--National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The CDC requests a three-year approval and a revision to the HIV 
Outpatient Study data collection activity. The HIV Outpatient Study 
(HOPS) is a prospective longitudinal cohort of HIV-infected outpatients 
at eight well-established private HIV care practices and university-
based U.S. clinics, in Tampa, Florida; Washington, DC; Stony Brook, New 
York; Chicago, Illinois; Denver, Colorado; and Philadelphia, 
Pennsylvania. Researchers abstract clinical data on an ongoing basis 
from the medical records of adult HIV-infected HOPS study participants, 
who also complete an optional telephone/Web-based behavioral assessment 
as part of their annual clinic visit, which on average takes about 
seven minutes. Before enrolling in this study, all potential study 
participants will undergo an informed consent process (including 
signing of a written informed consent), which is estimated to take 15 
minutes.
    The revisions consist of adding 12 additional survey questions to 
assess additional risk behaviors that may affect the long-term care and 
treatment of HIV positive patients participating in the HIV Outpatient 
Study. Based on review of the current survey response items and the 
average completion time, these new questions will not pose additional 
burden on participants.
    The core areas of HOPS research extending through the present HIV 
treatment era include: (i) Monitoring death rates and causes of death; 
(ii) characterizing the optimal patient management strategies to reduce 
HIV related morbidity and mortality (e.g., effectiveness of 
antiretroviral therapies and other clinical interventions); (iii) 
monitoring of sexual and drug use behaviors to inform Prevention with 
Positives; and (iv) investigating disparities in the HIV care continuum 
by various demographic factors.
    In recent years, the HOPS has been instrumental in bringing 
attention to emerging issues in chronic HIV infection with actionable 
opportunities for prevention, including cardiovascular disease, 
fragility fractures, renal and hepatic disease, and cancers. The HOPS 
remains an important source for multi-year trend data concerning 
conditions and behaviors for which data are not readily available 
elsewhere, to include: Rates of opportunistic illnesses, rates of 
comorbid conditions (e.g., hypertension, obesity, diabetes) and 
antiretroviral drug resistance.
    Researchers will collect data through medical record abstraction by 
trained abstractors and by telephone or Internet based, computer-
assisted interviews at eight funded study sites in six U.S. cities. 
Collection of data abstracted from patient medical records provides 
data in five general categories: Demographics and risk behaviors for 
HIV infection; symptoms; diagnosed conditions (definitive and 
presumptive); medications prescribed (including dose, duration, and 
reasons for stopping); all laboratory values, including CD4+ 
Tlymphocyte (CD4+) cell counts, plasma HIV-RNA determinations, and 
genotype, phenotype, and trophile results. Researchers will acquire 
data on visit frequency, AIDS, and death from the clinic chart. Data 
collected using a brief Telephone Audio-Computer Assisted Self-
Interview (T-ACASI) survey or an identical Web-based Audio-Computer 
Assisted Self-Interview (ACASI) include: Age, sex at birth, use of 
alcohol and drugs, cigarette smoking, adherence to antiretroviral 
medications, types of sexual intercourse, condom use, and disclosure of 
HIV status to partners.
    We anticipate the annual recruitment of 450 new HOPS study 
participants into the HOPS from a pool of HIV-infected individuals 
currently in HIV-care at nine clinics (50 patients per site). 
Researchers will approach patients during one of the patients' routine 
clinic visits to participate in the HOPS. Researchers will give 
patients interested in participating in the HOPS detailed information 
about the nature of the study and provide them with a written informed 
consent form that the patient must complete prior to enrollment. 
Annually, the researchers will add the 450 newly enrolled participants 
to the database of existing participants. Researchers will conduct 
medical record abstractions and will not impose direct burden on HOPS 
study participants.
    Participation of respondents is voluntary. There is no cost to the 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
HOPS study Patients...........  Behavioral                 2,500               1            7/60             292
                                 survey.
HOPS Study Patients...........  Consent form....             450               1           15/60             113
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             405
----------------------------------------------------------------------------------------------------------------



[[Page 44794]]

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. 2017-20511 Filed 9-25-17; 8:45 am]
BILLING CODE 4163-18-P
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