83 FR 43688 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 166 (August 27, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 166 (August 27, 2018)
| Page Range | 43688-43689 | |
| FR Document | 2018-18445 |
[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)] [Notices] [Pages 43688-43689] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18445] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-1080] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled [HIV Outpatient Study (HOPS)] to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ``Proposed Data Collection Submitted for Public Comment and Recommendations'' notice on [September 26, 2017] to obtain comments from the public and affected agencies. CDC received [2] comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. 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. 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]. 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 HIV Outpatient Study (HOPS) (OMB Control Number 0920-1080, Expiration Date 08/31/2018)--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 Centers for Disease Control and Prevention requests a three year approval for 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. Clinical data are abstracted on ongoing basis from the medical records of adult HIV- infected HOPS study participants, who also complete an optional seven minute telephone/web-based behavioral assessment as part of their annual clinic visit. 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 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, including: Rates of opportunistic illnesses, rates of comorbid conditions (e.g., hypertension, obesity, diabetes) and antiretroviral drug resistance. Data will be collected 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+ T- lymphocyte (CD4+) cell counts, plasma HIV-RNA determinations, and genotype, phenotype, and trophile results. Data on visit frequency, AIDS, and death are acquired 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 estimate consenting 450 new participants per year across all HOPS study sites (50 participants at each of the eight sites). The consent process takes approximately 15 minutes to complete. Medical record abstractions will be completed on all eligible participants. All eligible participants will be offered the opportunity to participate in an optional short survey that will take approximately seven minutes. Participation of respondents is voluntary. There is no cost to the [[Page 43689]] respondents other than their time. The estimated annual burden hours are 405. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- HOPS study Patients................ Behavioral survey (att 2,500 1 7/60 3a,b,9). HOPS Study Patients................ Consent form (att 4)....... 450 1 15/60 ---------------------------------------------------------------------------------------------------------------- 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. 2018-18445 Filed 8-24-18; 8:45 am] BILLING CODE 4163-18-P
![43688 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices
www.cdc.gov/niosh/nora/crosssectors/ (b) Evaluate the accuracy of the management strategies to reduce HIV-
ti/agenda.html. agencies estimate of the burden of the related morbidity and mortality (e.g.,
FOR FURTHER INFORMATION CONTACT: proposed collection of information, effectiveness of antiretroviral therapies
Emily Novicki, M.A., M.P.H, including the validity of the and other clinical interventions (iii)
(NORACoordinator@cdc.gov), National methodology and assumptions used; monitoring of sexual and drug use
Institute for Occupational Safety and (c) Enhance the quality, utility, and behaviors to inform Prevention with
Health, Centers for Disease Control and clarity of the information to be Positives, and (iv) investigating
Prevention, Mailstop E–20, 1600 Clifton collected; disparities in the HIV care continuum
Road NE, Atlanta, GA 30329, phone (d) Minimize the burden of the by various demographic factors. In
(404) 498–2581 (not a toll free number). collection of information on those who recent years, the HOPS has been
are to respond, including, through the instrumental in bringing attention to
SUPPLEMENTARY INFORMATION: On
use of appropriate automated, emerging issues in chronic HIV
December 7, 2017, NIOSH published a electronic, mechanical, or other
request for public review in the Federal infection with actionable opportunities
technological collection techniques or for prevention, including:
Register [82 FR 57758] of the draft other forms of information technology,
version of the National Occupational Cardiovascular disease, fragility
e.g., permitting electronic submission of fractures, renal and hepatic disease, and
Research Agenda for Traumatic Injury responses; and
Prevention. All comments received were cancers. The HOPS remains an
(e) Assess information collection important source for multi-year trend
reviewed and addressed where costs.
appropriate. data concerning conditions and
To request additional information on behaviors for which data are not readily
Dated: August 22, 2018. the proposed project or to obtain a copy available elsewhere, including: Rates of
Frank J. Hearl, of the information collection plan and opportunistic illnesses, rates of
Chief of Staff, National Institute for instruments, call (404) 639–7570 or comorbid conditions (e.g., hypertension,
Occupational Safety and Health, Centers for send an email to omb@cdc.gov. Direct obesity, diabetes) and antiretroviral drug
Disease Control and Prevention. written comments and/or suggestions resistance.
[FR Doc. 2018–18514 Filed 8–24–18; 8:45 am] regarding the items contained in this Data will be collected through
BILLING CODE 4163–19–P notice to the Attention: CDC Desk medical record abstraction by trained
Officer, Office of Management and abstractors and by telephone or internet-
Budget, 725 17th Street, NW, based, computer-assisted interviews at
DEPARTMENT OF HEALTH AND Washington, DC 20503 or by fax to (202) eight funded study sites in six U.S.
HUMAN SERVICES 395–5806. Provide written comments cities. Collection of data abstracted from
within 30 days of notice publication. patient medical records provides data in
Centers for Disease Control and
Proposed Project five general categories: Demographics
Prevention
HIV Outpatient Study (HOPS) (OMB and risk behaviors for HIV infection;
Control Number 0920–1080, Expiration symptoms; diagnosed conditions
[30Day–18–1080] (definitive and presumptive);
Date 08/31/2018)—REVISION—National
Center for HIV/AIDS, Viral Hepatitis, medications prescribed (including dose,
Agency Forms Undergoing Paperwork
STD, and TB Prevention (NCHHSTP), duration, and reasons for stopping); all
Reduction Act Review
Centers for Disease Control and laboratory values, including CD4+ T-
In accordance with the Paperwork Prevention (CDC). lymphocyte (CD4+) cell counts, plasma
Reduction Act of 1995, the Centers for HIV–RNA determinations, and
Disease Control and Prevention (CDC) Background and Brief Description genotype, phenotype, and trophile
has submitted the information The Centers for Disease Control and results. Data on visit frequency, AIDS,
collection request titled [HIV Outpatient Prevention requests a three year and death are acquired from the clinic
Study (HOPS)] to the Office of approval for the HIV Outpatient Study chart.
Management and Budget (OMB) for data collection activity. The HIV Data collected using a brief Telephone
review and approval. CDC previously Outpatient Study (HOPS) is a Audio-Computer Assisted Self-
published a ‘‘Proposed Data Collection prospective longitudinal cohort of HIV- Interview (T–ACASI) survey or an
Submitted for Public Comment and infected outpatients at eight well- identical web-based Audio-Computer
Recommendations’’ notice on established private HIV care practices Assisted Self-Interview (ACASI)
[September 26, 2017] to obtain and university-based U.S. clinics. include: age, sex at birth, use of alcohol
comments from the public and affected Clinical data are abstracted on ongoing and drugs, cigarette smoking, adherence
agencies. CDC received [2] comments basis from the medical records of adult to antiretroviral medications, types of
related to the previous notice. This HIV-infected HOPS study participants, sexual intercourse, condom use, and
notice serves to allow an additional 30 who also complete an optional seven disclosure of HIV status to partners.
days for public and affected agency minute telephone/web-based behavioral We estimate consenting 450 new
comments. assessment as part of their annual clinic participants per year across all HOPS
CDC will accept all comments for this visit. Before enrolling in this study, all study sites (50 participants at each of
proposed information collection project. potential study participants will the eight sites). The consent process
The Office of Management and Budget undergo an informed consent process takes approximately 15 minutes to
is particularly interested in comments (including signing of a written informed complete. Medical record abstractions
amozie on DSK3GDR082PROD with NOTICES1
that: consent) which is estimated to take 15 will be completed on all eligible
(a) Evaluate whether the proposed minutes. participants. All eligible participants
collection of information is necessary The core areas of HOPS research will be offered the opportunity to
for the proper performance of the extending through the present HIV participate in an optional short survey
functions of the agency, including treatment era include (i) monitoring that will take approximately seven
whether the information will have death rates and causes of death (ii) minutes. Participation of respondents is
practical utility; characterizing the optimal patient voluntary. There is no cost to the
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 43689
respondents other than their time. The
estimated annual burden hours are 405.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
HOPS study Patients ...................................... Behavioral survey (att 3a,b,9) ........................ 2,500 1 7/60
HOPS Study Patients ..................................... Consent form (att 4) ....................................... 450 1 15/60
Jeffrey M. Zirger, ADDRESSES: When commenting, please Plan Expansion Application
Acting Chief, Information Collection Review reference the document identifier or Regulations under 42 CFR 422
Office, Office of Scientific Integrity, Office OMB control number. To be assured (Subpart K) & 417.400
of the Associate Director for Science, Office consideration, comments and Under the PRA (44 U.S.C. 3501–
of the Director, Centers for Disease Control recommendations must be submitted in
and Prevention. 3520), federal agencies must obtain
any one of the following ways: approval from the Office of Management
[FR Doc. 2018–18445 Filed 8–24–18; 8:45 am] 1. Electronically. You may send your and Budget (OMB) for each collection of
BILLING CODE 4163–18–P comments electronically to http:// information they conduct or sponsor.
www.regulations.gov. Follow the The term ‘‘collection of information’’ is
instructions for ‘‘Comment or defined in 44 U.S.C. 3502(3) and 5 CFR
DEPARTMENT OF HEALTH AND Submission’’ or ‘‘More Search Options’’
HUMAN SERVICES 1320.3(c) and includes agency requests
to find the information collection or requirements that members of the
document(s) that are accepting public submit reports, keep records, or
Centers for Medicare & Medicaid
comments. provide information to a third party.
Services
2. By regular mail. You may mail Section 3506(c)(2)(A) of the PRA
written comments to the following requires federal agencies to publish a
[Document Identifier: CMS–10137 and CMS– address: CMS, Office of Strategic
10237] 60-day notice in the Federal Register
Operations and Regulatory Affairs, concerning each proposed collection of
Agency Information Collection Division of Regulations Development, information, including each proposed
Activities: Proposed Collection; Attention: Document Identifier/OMB extension or reinstatement of an existing
Comment Request Control Number ___, Room C4–26–05, collection of information, before
7500 Security Boulevard, Baltimore, submitting the collection to OMB for
AGENCY: Centers for Medicare & Maryland 21244–1850. approval. To comply with this
Medicaid Services, HHS. To obtain copies of a supporting requirement, CMS is publishing this
ACTION: Notice. statement and any related forms for the notice.
proposed collection(s) summarized in
SUMMARY: The Centers for Medicare & this notice, you may make your request Information Collection
Medicaid Services (CMS) is announcing using one of following: 1. Type of Information Collection
an opportunity for the public to 1. Access CMS’ website address at Request: Revision of a currently
comment on CMS’ intention to collect https://www.cms.gov/Regulations-and- approved collection; Title of
information from the public. Under the Guidance/Legislation/Paperwork Information Collection: Solicitation for
Paperwork Reduction Act of 1995 (the ReductionActof1995/PRA-Listing.html. Applications for Medicare Prescription
PRA), federal agencies are required to 2. Email your request, including your Drug Plan 2020 Contracts; Use: Coverage
publish notice in the Federal Register address, phone number, OMB number, for the prescription drug benefit is
concerning each proposed collection of and CMS document identifier, to provided through contracted
information (including each proposed Paperwork@cms.hhs.gov. prescription drug plans (PDPs) or
extension or reinstatement of an existing 3. Call the Reports Clearance Office at through Medicare Advantage (MA)
collection of information) and to allow (410) 786–1326. plans that offer integrated prescription
60 days for public comment on the FOR FURTHER INFORMATION CONTACT: drug and health care coverage (MA–PD
proposed action. Interested persons are William Parham at (410) 786–1326. plans). Cost Plans that are regulated
invited to send comments regarding our SUPPLEMENTARY INFORMATION: under Section 1876 of the Social
burden estimates or any other aspect of Security Act, and Employer Group
this collection of information, including Contents
Waiver Plans (EGWP) may also provide
the necessity and utility of the proposed This notice sets out a summary of the a Part D benefit. Organizations wishing
information collection for the proper use and burden associated with the to provide services under the
performance of the agency’s functions, following information collections. More Prescription Drug Benefit Program must
the accuracy of the estimated burden, detailed information can be found in complete an application, negotiate rates,
ways to enhance the quality, utility, and each collection’s supporting statement and receive final approval from CMS.
amozie on DSK3GDR082PROD with NOTICES1
clarity of the information to be and associated materials (see Existing Part D Sponsors may also
collected, and the use of automated ADDRESSES). expand their contracted service area by
collection techniques or other forms of CMS–10137 Solicitation for completing the Service Area Expansion
information technology to minimize the Applications for Medicare (SAE) application.
information collection burden. Prescription Drug Plan 2020 Contracts Collection of this information is
DATES: Comments must be received by CMS–10237 Medicare Advantage mandated in Part D of the Medicare
October 26, 2018. Application—Part C and 1876 Cost Prescription Drug, Improvement, and
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Document Created: 2018-08-25 01:48:04
Document Modified: 2018-08-25 01:48:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 43688 |
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