82 FR 39440 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 159 (August 18, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 159 (August 18, 2017)
| Page Range | 39440-39442 | |
| FR Document | 2017-17495 |
[Federal Register Volume 82, Number 159 (Friday, August 18, 2017)] [Notices] [Pages 39440-39442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17495] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10437 and CMS-10652] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by September 18, 2017. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR, Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. [[Page 39441]] 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669. 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. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Generic Social Marketing & Consumer Testing Research; Use: The purpose of this submission is to extend the approval of the generic clearance for a program of consumer research aimed at a broad audience of those affected by CMS programs including Medicare, Medicaid, Children's Health Insurance Program (CHIP), and health insurance exchanges. This program extends strategic efforts to reach and tailor communications to beneficiaries, caregivers, providers, stakeholders, and any other audiences that would support the Agency in improving the functioning of the health care system, improve patient care and outcomes, and reduce costs without sacrificing quality of care. The information collected will be used to create a streamlined and proactive process for collection of data and utilizing the feedback on service delivery for continuous improvement of communication activities aimed at diverse CMS audiences. The generic clearance will allow rapid response to inform CMS initiatives using a mixture of qualitative and quantitative consumer research strategies (including formative research studies and methodological tests) to improve communication with key CMS audiences. As new information resources and persuasive technologies are developed, they can be tested and evaluated for beneficiary response to the materials and delivery channels. Results will inform communication development and information architecture as well as allow for continuous quality improvement. The overall goal is to maximize the extent to which consumers have access to useful sources of CMS program information in a form that can help them make the most of their benefits and options. The activities under this clearance involve social marketing and consumer research using samples of self-selected customers, as well as convenience samples, and quota samples, with respondents selected either to cover a broad range of customers or to include specific characteristics related to certain products or services. All collection of information under this clearance will utilize a subset of items drawn from a core collection of customizable items referred to as the Social Marketing and Consumer Testing Item Bank. This item bank is designed to establish a set of pre-approved generic question that can be drawn upon to allow for the rapid turn-around consumer testing required for us to communicate more effectively with our audiences. The questions in the item bank are divided into two major categories. One set focuses on characteristics of individuals and is intended primarily for participant screening and for use in structured quantitative on- line or telephone surveys. The other set is less structured and is designed for use in qualitative one-on-one and small group discussions or collecting information related to subjective impressions of test materials. Results will be compiled and disseminated so that future communication can be informed by the testing results. We will use the findings to create the greatest possible public benefit. Form Number: CMS-10437 (OMB control number: 0938-1247); Frequency: Yearly; Affected Public: Individuals; Number of Respondents: 41,592; Number of Responses: 28,800; Total Annual Hours: 21,488. (For policy questions regarding this collection contact Allyssa Allen at 410-786-8436126.) 2. Type of Information Collection Request: New collection of information request; Title of Information Collection: Virtual Groups for Merit-Based Incentive Payment System (MIPS); Use: CMS acknowledges the unique challenges that small practices and practices in rural areas may face with the implementation of the Quality Payment Program. To help support these practices and provide them with additional flexibility, CMS has created a virtual group reporting option starting with the 2018 MIPS performance period. CMS held webinars and small, interactive feedback sessions to gain insight from clinicians as we developed our policies on virtual groups. During these sessions, participants expressed a strong interest in virtual groups, and indicated that the right policies could minimize clinician burden and bolster clinician success. This information collection request is related to the statutorily required virtual group election process proposed in the CY 2018 Quality Payment Program proposed rule. A virtual group is a combination of Tax Identification Numbers (TINs), which would include at least two separate TINs associated with a solo practitioner TIN and National Provider Identifier (TIN/NPI) or group with 10 or fewer MIPS eligible clinicians and another solo practitioner (TIN/NPI) or group with 10 or fewer MIPS eligible clinicians. Section 1848(q)(5)(I) of the Act requires that CMS establish and have in place a process to allow an individual MIPS eligible clinician or group consisting of not more than 10 MIPS eligible clinicians to elect, with respect to a performance period for a year to be in a virtual group with at least one other such individual MIPS eligible clinician or group. The Act also provides for the use of voluntary virtual groups for certain assessment purposes, including the election of practices to be a virtual group and the requirements for the election process. Section 1848(q)(5)(I)(i) of the Act also provides that MIPS eligible clinicians electing to be a virtual group must: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all the MIPS eligible clinicians in the virtual group to each MIPS eligible clinician in the virtual group for the applicable performance period; and (2) be scored for the quality and cost performance categories based on such assessment. CMS will use the data collected from virtual group representatives to determine eligibility to participate in a virtual group, approve the formation of that virtual group, based on determination of each TIN size, and assign a virtual group identifier to the virtual group. The data collected will also be used to assign a performance score to each TIN/NPI in the virtual group. Form Number: CMS-10652 (OMB control number: 0938-NEW); [[Page 39442]] Frequency: Annually; Affected Public: Private Sector: Business or other for-profits and Not-for-profit institutions and Individuals; Number of Respondents: 16; Total Annual Responses: 16; Total Annual Hours: 160. (For policy questions regarding this collection contact Michelle Peterman at 410-786-2591.) Dated: August 15, 2017. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-17495 Filed 8-17-17; 8:45 am] BILLING CODE 4120-01-P
![39440 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices
Implementing Industry Standards.3 This the prevention of Legionella growth and DEPARTMENT OF HEALTH AND
toolkit is dedicated to developing and transmission? HUMAN SERVICES
implementing WMPs and can inform (2) Are there other standards or
conversations with building owners and guidance for the prevention of Centers for Medicare & Medicaid
managers on how to reduce the risk of Legionella growth and transmission that Services
Legionella growth and transmission in you would find useful but do not exist [Document Identifier: CMS–10437 and CMS–
their building water systems. or are not currently available to you? If 10652]
so, what information should those
Information Needs
standards or guidance contain? Agency Information Collection
While a consensus standard and (3) What is your organization’s role, Activities: Submission for OMB
guidance exist regarding development and your role within the organization, Review; Comment Request
and implementation of WMPs, there are in achieving implementation of WMPs
gaps regarding the most effective by owners and managers of buildings at AGENCY: Centers for Medicare &
methods to encourage WMP increased risk for Legionella growth and Medicaid Services, HHS.
implementation. A variety of transmission? ACTION: Notice.
stakeholders (e.g., public health (4) In your organization’s experience,
partners, industry leaders, accreditation what are the principal barriers to SUMMARY: The Centers for Medicare &
or licensing bodies) routinely work with implementation of WMPs by building Medicaid Services (CMS) is announcing
building owners and managers on owners and managers? an opportunity for the public to
WMPs or on related policies. However, (5) Where there are barriers, what has comment on CMS’ intention to collect
successful communication and your organization done to overcome information from the public. Under the
implementation of WMPs can be these barriers? Paperwork Reduction Act of 1995
challenging, and more information is (6) Where implementation of WMPs (PRA), federal agencies are required to
needed on how implementation of has gone smoothly, what factors (e.g., publish notice in the Federal Register
WMPs can be improved. CDC seeks resources, guidance, activities) concerning each proposed collection of
public comments in response to the contributed to this success? information, including each proposed
following questions to guide best (7) Has your organization had extension or reinstatement of an existing
practices, especially regarding the experience with approaches to WMP collection of information, and to allow
dissemination and implementation of implementation that are specific to a second opportunity for public
WMPs. The information gathered will certain settings (e.g., hotels, hospitals) comment on the notice. Interested
be used to guide best practices regarding or devices (e.g., cooling towers, potable persons are invited to send comments
effective strategies to prevent water)? If so, have you learned anything regarding the burden estimate or any
Legionnaires disease in the United from these different approaches that other aspect of this collection of
States. Information gathered can also could be used to improve WMP information, including the necessity and
inform efforts to prevent disease due to implementation? Have you looked for or utility of the proposed information
other waterborne pathogens. experienced any unintended collection for the proper performance of
Please feel free to respond to any or consequences related to a WMP? the agency’s functions, the accuracy of
all of the questions. Possible domains to (8) A limited number of jurisdictions the estimated burden, ways to enhance
consider in answering these questions have implemented regulations to reduce the quality, utility, and clarity of the
include (but are not limited to): the risk of Legionella growth and information to be collected, and the use
of automated collection techniques or
• Local knowledge about Legionnaires transmission (e.g., New York, New York
City). In your state or local jurisdiction, other forms of information technology to
disease, Legionella growth, and
should building codes or other types of minimize the information collection
prevention strategies
• Stakeholder engagement (key public health regulation or legislation be burden.
supporters and opponents) used to help prevent Legionnaires’ DATES:Comments on the collection(s) of
• Feasibility of WMP implementation disease? Why or why not? information must be received by the
• Costs and benefits of WMP (9) Are there other approaches to OMB desk officer by September 18,
implementation reducing the risk of Legionnaires’ 2017.
• Availability of effective disease that your organization has found
to be useful besides implementation of ADDRESSES: When commenting on the
communication strategies
proposed information collections,
• Possible impact of proposed solutions WMPs?
(10) What additional considerations please reference the document identifier
including unintended consequences
are relevant to developing guidance for or OMB control number. To be assured
such as degradation of plumbing
preventing Legionnaires disease? consideration, comments and
infrastructure or pathogen
(11) Has your organization recommendations must be received by
substitution (e.g., remediation
implemented specific approaches to the OMB desk officer via one of the
directed at one pathogen, such as
reducing the risk of disease due to other following transmissions: OMB, Office of
Legionella, leading to increases in a
opportunistic waterborne pathogens Information and Regulatory Affairs,
second pathogen, such as
besides Legionella? If so, please explain. Attention: CMS Desk Officer, Fax
nontuberculous mycobacteria)
• Historical context in which a WMP Do these approaches conflict in any way Number: (202) 395–5806 OR, Email:
was or was not adopted with your approaches to reducing the OIRA_submission@omb.eop.gov.
• Influence of local regulations To obtain copies of a supporting
mstockstill on DSK30JT082PROD with NOTICES
risk of Legionnaires disease?
statement and any related forms for the
Questions Dated: August 15, 2017. proposed collection(s) summarized in
Sandra Cashman, this notice, you may make your request
(1) What existing standards or
guidance does your organization use for Executive Secretary, Centers for Disease using one of following:
Control and Prevention. 1. Access CMS’ Web site address at
3 https://www.cdc.gov/legionella/downloads/ [FR Doc. 2017–17491 Filed 8–17–17; 8:45 am] http://www.cms.hhs.gov/
toolkit.pdf. BILLING CODE 4163–18–P PaperworkReductionActof1995.
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![39442 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices
Frequency: Annually; Affected Public: dyslipidemia (Frederickson Types IIa The meeting will be open to the
Private Sector: Business or other for- and IIb) when the response to dietary public as indicated below, with
profits and Not-for-profit institutions restriction of saturated fat and attendance limited to space available.
and Individuals; Number of cholesterol and other non- Individuals who plan to attend and
Respondents: 16; Total Annual pharmacological measures alone has need special assistance, such as sign
Responses: 16; Total Annual Hours: been inadequate. Supplemental NDAs language interpretation or other
160. (For policy questions regarding this were received by FDA on July 17, 1998, reasonable accommodations, should
collection contact Michelle Peterman at for the 0.4 mg strength of the drug notify the Contact Person listed below
410–786–2591.) (approved on May 24, 1999) and on in advance of the meeting.
Dated: August 15, 2017. September 23, 1999, for the 0.8 mg The meeting will be closed to the
strength of the drug (approved on July public in accordance with the
Martique Jones,
21, 2000). The most recently approved provisions set forth in sections
Director, Regulations Development Group, labeling (May 21, 2001) for this drug
Office of Strategic Operations and Regulatory 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
stated that: ‘‘BAYCOL® (cerivastatin
Affairs. as amended. The grant applications and
sodium tablets) is indicated as an
[FR Doc. 2017–17495 Filed 8–17–17; 8:45 am] the discussions could disclose
adjunct to diet to reduce elevated
BILLING CODE 4120–01–P confidential trade secrets or commercial
Total–C, LDL–C, apo B, and TG and to
property such as patentable material,
increase HDL–C levels in patients with
and personal information concerning
primary hypercholesterolemia and
DEPARTMENT OF HEALTH AND individuals associated with the grant
mixed dyslipidemia (Fredrickson Types
HUMAN SERVICES applications, the disclosure of which
IIa and IIb) when the response to dietary
would constitute a clearly unwarranted
Food and Drug Administration restriction of saturated fat and
invasion of personal privacy.
cholesterol and other non-
[Docket No. FDA–2017–N–4069] pharmacological measures alone has Name of Committee: National Advisory
been inadequate.’’ Mental Health Council.
Bayer Healthcare Pharmaceuticals; Over time, however, reports Date: September 14, 2017.
Withdrawal of Approval of a New Drug associating cerivastatin with Open: 9:00 a.m. to 12:45 p.m.
Application for BAYCOL (cerivastatin rhabdomyolysis, a potentially fatal Agenda: Presentation of the NIMH
sodium) Tablets, 0.05 Milligrams, 0.1 Director’s Report and discussion.
condition involving muscle weakness,
Milligrams, 0.2 Milligrams, 0.3 Place: National Institutes of Health,
increased. Because of these reports, Neuroscience Center, 6001 Executive
Milligrams, 0.4 Milligrams, and 0.8 Bayer withdrew BAYCOL from the
Milligrams Boulevard, Rockville, MD 20852.
market on August 8, 2001. On January Closed: 2:00 p.m. to 5:00 p.m.
AGENCY: Food and Drug Administration, 24, 2014, Bayer wrote to FDA asking the Agenda: To review and evaluate grant
HHS. Agency to withdraw approval of NDA applications and/or proposals.
ACTION: Notice. 020740 under 21 CFR 314.150(d) and Place: National Institutes of Health,
waived its opportunity for a hearing. Neuroscience Center, 6001 Executive
SUMMARY: The Food and Drug Accordingly, under section 505(e) of Boulevard, Rockville, MD 20852.
Administration (FDA) is withdrawing the FD&C Act (21 U.S.C. 355(e)) and Contact Person: Jean G. Noronha, Ph.D.,
approval of new drug application (NDA) section 314.150(d), approval of NDA Director, Division of Extramural Activities,
020740 for BAYCOL (cerivastatin 020740, and all amendments and National Institute of Mental Health, NIH
sodium) tablets, 0.05 milligrams (mg), supplements thereto, is withdrawn. Neuroscience Center, 6001 Executive Blvd.,
Distribution of BAYCOL (cerivastatin Room 6154, MSC 9609, Bethesda, MD 20892–
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8
9609, 301–443–3367, jnoronha@mail.nih.gov.
mg, held by Bayer Healthcare sodium) tablets, 0.05 mg, 0.1 mg, 0.2
Pharmaceuticals (Bayer). Bayer mg, 0.3 mg, 0.4 mg, and 0.8 mg in Any member of the public interested in
interstate commerce without an presenting oral comments to the committee
requested withdrawal of this
may notify the Contact Person listed on this
application, and has waived its approved application is illegal and notice at least 10 days in advance of the
opportunity for a hearing. subject to regulatory action (see sections meeting. Interested individuals and
DATES: Approval is withdrawn as of 505(a) and 301(d) of the FD&C Act (21 representatives of organizations may submit
August 18, 2017. U.S.C. 355(a) and 331(d)). a letter of intent, a brief description of the
FOR FURTHER INFORMATION CONTACT: Dated: August 15, 2017. organization represented, and a short
Kristiana Brugger, Office of Regulatory Leslie Kux, description of the oral presentation. Only one
representative of an organization may be
Policy, Center for Drug Evaluation and Associate Commissioner for Policy.
allowed to present oral comments and if
Research, Food and Drug [FR Doc. 2017–17510 Filed 8–17–17; 8:45 am] accepted by the committee, presentations
Administration, 10903 New Hampshire BILLING CODE 4164–01–P may be limited to five minutes. Both printed
Ave., Bldg. 51, Rm. 6262, Silver Spring, and electronic copies are requested for the
MD 20993, 301–796–3600. record. In addition, any interested person
SUPPLEMENTARY INFORMATION: NDA DEPARTMENT OF HEALTH AND may file written comments with the
020740 for BAYCOL (cerivastatin HUMAN SERVICES committee by forwarding their statement to
sodium) tablets, 0.05 mg, 0.1 mg, 0.2 the Contact Person listed on this notice. The
mg, and 0.3 mg, was received on June National Institutes of Health statement should include the name, address,
26, 1996, under section 505(b) of the telephone number and when applicable, the
mstockstill on DSK30JT082PROD with NOTICES
National Institute of Mental Health; business or professional affiliation of the
Federal Food, Drug, and Cosmetic Act
Notice of Meeting interested person.
(FD&C Act). FDA approved NDA 020740 Information is also available on the
on June 26, 1997, as safe and effective Pursuant to section 10(d) of the Institute’s/Center’s home page:
as an adjunct to diet for the reduction Federal Advisory Committee Act, as www.nimh.nih.gov/about/advisory-boards-
of elevated total and LDL cholesterol amended, notice is hereby given of a and-groups/namhc/index.shtml., where an
levels in patients with primary meeting of the National Advisory agenda and any additional information for
hypercholesterolemia and mixed Mental Health Council. the meeting will be posted when available.
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Document Created: 2017-08-18 07:40:56
Document Modified: 2017-08-18 07:40:56
| 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. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by September 18, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 39440 |
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