82 FR 27832 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 116 (June 19, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 116 (June 19, 2017)
| Page Range | 27832-27833 | |
| FR Document | 2017-12736 |
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)] [Notices] [Pages 27832-27833] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12736] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-17ACE; Docket No. CDC-2017-0043] 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 a proposed information collection entitled ``Evaluation of Medication-Assisted Treatment (MAT) for Opioid use disorder.'' CDC will use the collection to conduct an epidemiologic study to assess the type of MAT (methadone maintenance; buprenorphine; naltrexone; or, counseling, no MAT), and the contextual, provider, and individual factors that influence implementation and improved patient wellbeing over a two-year follow up period. DATES: Written comments must be received on or before August 18, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2017- 0043 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: [email protected]. 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 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 [[Page 27833]] 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 Evaluation of Medication-Assisted Treatment (MAT) for Opioid use disorder--New--National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC seeks a three-year OMB approval to collect evaluation information for Medication-Assisted Treatment (MAT) for Opioid use disorder. About 2.4 million people aged 18 or older have opioid use disorders (OUDs) in the United States. At any given time, only half of these people receive some form of treatment, which may include medication- assisted treatment (MAT) or abstinence-based psychotherapy or self-help treatments (i.e., counseling without medication [COUN]). The rise in opioid overdose deaths, up from 2014-2015 due partly to a 72% rise in synthetic opioid overdose deaths alone, shows that engaging and retaining clients in OUD treatment is an urgent public health need. Only a few studies are available to help clients and providers make informed decisions about the risks and benefits associated with the different types of MATs. This information is crucial because even though each MAT drug helps prevent withdrawal symptoms and decreases cravings, differences in treatment approach and settings influence how people respond to the medication and, thus, their long-term treatment success. The purpose of this evaluation is to conduct an epidemiologic, mixed-methods evaluation of OUD treatment in real-world outpatient settings. The study aims to have 3,000 participants from real-world outpatient settings to better understand the relationship between type of MAT and individual, provider, and contextual characteristics related to retention in treatment and abstinence from opioid use. The sites will be located across 10 diverse metropolitan statistical areas (MSAs) with four sites in each MSA. At each site, about 75 participants are expected to participate for a total of 300 per MSA. Across all MSAs, the study will aim to have 750 client participants in each of the four treatment conditions (MMT, BUP, NAL, and COUN). The study will use a mixed-method approach using quantitative methods such as multilevel latent growth models, propensity score matching, latent class analysis and advance mediation analysis and qualitative methods such as interactive coding and analysis for common themes. The only cost to respondents will be time spent responding to the survey/screener. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Instrument name Number of responses per per response Total burden respondents respondent (hours) (hours) ---------------------------------------------------------------------------------------------------------------- Provider site staff........... Client 15 100 5/60 125 Permission Form. Visit Form...... 15 525 10/60 1,313 Site Director 15 2 1 30 Questionnaire. Focus Groups.... 27 1 90/60 41 Client respondents............ Client Screener. 1,333 1 5/60 111 Client Check-in. 1,000 2 15/60 500 Client 2,412 1 49/60 1,978 Questionnaire. Focus Groups.... 27 1 90/60 41 Total..................... 4,139 ---------------------------------------------------------------------------------------------------------------- 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. 2017-12736 Filed 6-16-17; 8:45 am] BILLING CODE 4163-18-P
![27832 Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
DGMQ will review a permit Reduction Act (44 U.S.C. 3507) and Docket Number. All relevant comments
application within 3–5 business days of assigned the following OMB control received will be posted without change
receiving the application and apply the number: Foreign Quarantine: OMB to Regulations.gov, including any
criteria in Federal Register notice Control No. 0920–0134, expiration date personal information provided. For
published at 79 FR 39403 (July 20, 5/31/2019. access to the docket to read background
2014). If the application is approved, a Dated: June 12, 2017. documents or comments received, go to
permit will be emailed to the dog’s Sandra Cashman, Regulations.gov.
owner. The owner must present the Please note: All public comment should be
Executive Secretary, Centers for Disease
permit to the Customs and Border Control and Prevention. submitted through the Federal eRulemaking
Protection (CBP) officer at the first portal (Regulations.gov) or by U.S. mail to the
[FR Doc. 2017–12439 Filed 6–16–17; 8:45 am]
arriving port of entry into the United address listed above.
BILLING CODE 4163–18–P
States. The permit will be collected by
FOR FURTHER INFORMATION CONTACT: To
the CBP officer and sent to CDC.
If the permit application is denied, request more information on the
DEPARTMENT OF HEALTH AND proposed project or to obtain a copy of
DGMQ will email the reasons for the
HUMAN SERVICES the information collection plan and
denial to the dog’s owner within 3–5
business days of receiving the instruments, contact Leroy A.
Centers for Disease Control and Richardson, Information Collection
application. The email will include Prevention
instructions on whom to contact, Review Office, Centers for Disease
including name, address, and telephone [60Day–17–17ACE; Docket No. CDC–2017– Control and Prevention, 1600 Clifton
number, if the dog’s owner has any 0043] Road, NE., MS–D74, Atlanta, Georgia
questions, as well as information on 30329; phone: 404–639–7570; Email:
Proposed Data Collection Submitted omb@cdc.gov.
how to submit an appeal. In accordance for Public Comment and
with current procedures, individuals SUPPLEMENTARY INFORMATION: Under the
Recommendations Paperwork Reduction Act of 1995 (PRA)
who wish to contest CDC’s
determination will have five business AGENCY: Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies
days after receiving the denial to submit Prevention (CDC), Department of Health must obtain approval from the Office of
a written appeal. The individual must and Human Services (HHS). Management and Budget (OMB) for each
submit the appeal via email to ACTION: Notice with comment period.
collection of information they conduct
cdcanimalimports@cdc.gov, state the or sponsor. In addition, the PRA also
reasons for the appeal, and show that SUMMARY: The Centers for Disease requires Federal agencies to provide a
there is a genuine and substantial issue Control and Prevention (CDC), as part of 60-day notice in the Federal Register
of fact in dispute. CDC will issue a its continuing efforts to reduce public concerning each proposed collection of
response via email, which will burden and maximize the utility of information, including each new
constitute final agency action. The government information, invites the proposed collection, each proposed
appeal will be reviewed and decided general public and other Federal extension of existing collection of
upon by a CDC senior management agencies to take this opportunity to information, and each reinstatement of
official who is senior to the employee comment on proposed and/or previously approved information
who denied the initial permit continuing information collections, as collection before submitting the
application. In keeping with current required by the Paperwork Reduction collection to OMB for approval. To
practice, a successful appeal of a denial Act of 1995. This notice invites comply with this requirement, we are
only permits the owner to import the comment on a proposed information publishing this notice of a proposed
dog into the United States at a later date collection entitled ‘‘Evaluation of data collection as described below.
under the requirements set forth in a Medication-Assisted Treatment (MAT) Comments are invited on: (a) Whether
dog import permit. The appeal does not for Opioid use disorder.’’ CDC will use the proposed collection of information
entitle the owner to recover any costs the collection to conduct an is necessary for the proper performance
related to returning a dog that has been epidemiologic study to assess the type of the functions of the agency, including
denied entry to its country of origin and of MAT (methadone maintenance; whether the information shall have
reimporting the dog into the United buprenorphine; naltrexone; or, practical utility; (b) the accuracy of the
States. An owner or owner’s agent will counseling, no MAT), and the agency’s estimate of the burden of the
not be allowed to board a dog or arrange contextual, provider, and individual proposed collection of information; (c)
for its confinement at a port of entry factors that influence implementation ways to enhance the quality, utility, and
pending a determination regarding the and improved patient wellbeing over a clarity of the information to be
importer’s application to import an two-year follow up period. collected; (d) ways to minimize the
inadequately immunized dog. DATES: Written comments must be burden of the collection of information
Accordingly, inadequately immunized received on or before August 18, 2017. on respondents, including through the
dogs arriving at a port of entry without ADDRESSES: You may submit comments, use of automated collection techniques
an approved permit will be denied entry identified by Docket No. CDC–2017– or other forms of information
into the United States and re-exported 0043 by any of the following methods: technology; and (e) estimates of capital
to its country of origin at the owner’s • Federal eRulemaking Portal: or start-up costs and costs of operation,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
expense. Regulations.gov. Follow the instructions maintenance, and purchase of services
for submitting comments. to provide information. Burden means
III. Paperwork Reduction Act • Mail: Leroy A. Richardson, the total time, effort, or financial
This change does not institute a new Information Collection Review Office, resources expended by persons to
collection of information. The collection Centers for Disease Control and generate, maintain, retain, disclose or
of information, has been previously Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal
approved by the Office of Management D74, Atlanta, Georgia 30329. agency. This includes the time needed
and Budget (OMB) in accordance with Instructions: All submissions received to review instructions; to develop,
the requirements of the Paperwork must include the agency name and acquire, install and utilize technology
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![Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices 27833
and systems for the purpose of in the United States. At any given time, real-world outpatient settings. The
collecting, validating and verifying only half of these people receive some study aims to have 3,000 participants
information, processing and form of treatment, which may include from real-world outpatient settings to
maintaining information, and disclosing medication-assisted treatment (MAT) or better understand the relationship
and providing information; to train abstinence-based psychotherapy or self- between type of MAT and individual,
personnel and to be able to respond to help treatments (i.e., counseling without provider, and contextual characteristics
a collection of information, to search medication [COUN]). The rise in opioid related to retention in treatment and
data sources, to complete and review overdose deaths, up from 2014–2015 abstinence from opioid use. The sites
the collection of information; and to due partly to a 72% rise in synthetic will be located across 10 diverse
transmit or otherwise disclose the opioid overdose deaths alone, shows metropolitan statistical areas (MSAs)
information. that engaging and retaining clients in with four sites in each MSA. At each
OUD treatment is an urgent public site, about 75 participants are expected
Proposed Project
health need. Only a few studies are to participate for a total of 300 per MSA.
Evaluation of Medication-Assisted available to help clients and providers Across all MSAs, the study will aim to
Treatment (MAT) for Opioid use make informed decisions about the risks have 750 client participants in each of
disorder—New—National Center for and benefits associated with the the four treatment conditions (MMT,
Injury Prevention and Control (NCIPC), different types of MATs. This BUP, NAL, and COUN).
Centers for Disease Control and information is crucial because even The study will use a mixed-method
Prevention (CDC). though each MAT drug helps prevent approach using quantitative methods
withdrawal symptoms and decreases such as multilevel latent growth models,
Background and Brief Description
cravings, differences in treatment propensity score matching, latent class
CDC seeks a three-year OMB approval approach and settings influence how analysis and advance mediation
to collect evaluation information for people respond to the medication and, analysis and qualitative methods such
Medication-Assisted Treatment (MAT) thus, their long-term treatment success. as interactive coding and analysis for
for Opioid use disorder. The purpose of this evaluation is to common themes. The only cost to
About 2.4 million people aged 18 or conduct an epidemiologic, mixed- respondents will be time spent
older have opioid use disorders (OUDs) methods evaluation of OUD treatment in responding to the survey/screener.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Instrument name responses per
respondents response (hours)
respondent (hours)
Provider site staff .............................. Client Permission Form .................... 15 100 5/60 125
Visit Form ......................................... 15 525 10/60 1,313
Site Director Questionnaire .............. 15 2 1 30
Focus Groups ................................... 27 1 90/60 41
Client respondents ............................ Client Screener ................................ 1,333 1 5/60 111
Client Check-in ................................. 1,000 2 15/60 500
Client Questionnaire ......................... 2,412 1 49/60 1,978
Focus Groups ................................... 27 1 90/60 41
Total ........................................... 4,139
Leroy A. Richardson, Administration for Native Americans’ consolidate staffing into one field for
Chief, Information Collection Review Office, (ANA) Objective Work Plan (OWP) and both lead and support staff.
Office of Scientific Integrity, Office of the Objective Progress Report (OPR). The ANA will require applicants to
Associate Director for Science, Office of the OWP is used by applicants when they differentiate between administrative
Director, Centers for Disease Control and activities and milestone activities.
submit their proposals and then by
Prevention. Administrative activities are those
grantees to monitor their projects once
[FR Doc. 2017–12736 Filed 6–16–17; 8:45 am] directly related to grant administration,
the award is made by ANA. Slight
BILLING CODE 4163–18–P
content changes are proposed for the such as reporting and attending post-
OWP approved under information award training. Milestone activities are
collection OMB No. 0970–0452, key activities needed to complete
DEPARTMENT OF HEALTH AND project objectives. These activities may
HUMAN SERVICES Expiration Date 6/30/2018. An
extension of expiration date is also result in a single output; therefore ANA
requested. This will streamline the will require applicants to identify
Administration for Children and
outputs related to milestone activities as
Families information collection and reduce the
necessary.
number of elements.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Proposed Information Collection OPR: Currently, ANA requires
OWP: The following are proposed grantees to report on the status of results
Activity; Comment Request
content changes to the document: ANA and benefits in the OPR. This section
Title: Administration for Native proposes to eliminate Problem will be deleted as ANA no longer
Americans Objective Work Plan (OWP) Statement and Results and Benefits and requires grantees to identify results or
and Objective Progress Report (OPR). Criteria for Evaluation of results and benefits from their project, just
OMB No.: 0970–0452. benefits from the OWP. These elements outcomes. Outcomes will be reported
Description: Content and formatting will no longer be required by applicants annually in a separate OMB approved
changes are being made to the for ANA discretionary grants. ANA will form.
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Document Created: 2017-06-17 01:47:49
Document Modified: 2017-06-17 01:47:49
| 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 | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before August 18, 2017. | |
| 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: [email protected] | |
| FR Citation | 82 FR 27832 |
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