39440 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices 

3https://www.cdc.gov/legionella/downloads/

toolkit.pdf. 

Implementing Industry Standards.3 This 

toolkit is dedicated to developing and 

implementing WMPs and can inform 

conversations with building owners and 

managers on how to reduce the risk of 

Legionella growth and transmission in 

their building water systems. 

Information Needs 

While a consensus standard and 

guidance exist regarding development 

and implementation of WMPs, there are 

gaps regarding the most effective 

methods to encourage WMP 

implementation. A variety of 

stakeholders (e.g., public health 

partners, industry leaders, accreditation 

or licensing bodies) routinely work with 

building owners and managers on 

WMPs or on related policies. However, 

successful communication and 

implementation of WMPs can be 

challenging, and more information is 

needed on how implementation of 

WMPs can be improved. CDC seeks 

public comments in response to the 

following questions to guide best 

practices, especially regarding the 

dissemination and implementation of 

WMPs. The information gathered will 

be used to guide best practices regarding 

effective strategies to prevent 

Legionnaires disease in the United 

States. Information gathered can also 

inform efforts to prevent disease due to 

other waterborne pathogens. 

Please feel free to respond to any or 

all of the questions. Possible domains to 

consider in answering these questions 

include (but are not limited to): 

• Local knowledge about Legionnaires 

disease, Legionella growth, and 

prevention strategies 

• Stakeholder engagement (key 

supporters and opponents) 

• Feasibility of WMP implementation 

• Costs and benefits of WMP 

implementation 

• Availability of effective 

communication strategies 

• Possible impact of proposed solutions 

including unintended consequences 

such as degradation of plumbing 

infrastructure or pathogen 

substitution (e.g., remediation 

directed at one pathogen, such as 

Legionella, leading to increases in a 

second pathogen, such as 

nontuberculous mycobacteria) 

• Historical context in which a WMP 

was or was not adopted 

• Influence of local regulations 

Questions 

(1) What existing standards or 

guidance does your organization use for 

the prevention of Legionella growth and 

transmission? 

(2) Are there other standards or 

guidance for the prevention of 

Legionella growth and transmission that 

you would find useful but do not exist 

or are not currently available to you? If 

so, what information should those 

standards or guidance contain? 

(3) What is your organization’s role, 

and your role within the organization, 

in achieving implementation of WMPs 

by owners and managers of buildings at 

increased risk for Legionella growth and 

transmission? 

(4) In your organization’s experience, 

what are the principal barriers to 

implementation of WMPs by building 

owners and managers? 

(5) Where there are barriers, what has 

your organization done to overcome 

these barriers? 

(6) Where implementation of WMPs 

has gone smoothly, what factors (e.g., 

resources, guidance, activities) 

contributed to this success? 

(7) Has your organization had 

experience with approaches to WMP 

implementation that are specific to 

certain settings (e.g., hotels, hospitals) 

or devices (e.g., cooling towers, potable 

water)? If so, have you learned anything 

from these different approaches that 

could be used to improve WMP 

implementation? Have you looked for or 

experienced any unintended 

consequences related to a WMP? 

(8) A limited number of jurisdictions 

have implemented regulations to reduce 

the risk of Legionella growth and 

transmission (e.g., New York, New York 

City). In your state or local jurisdiction, 

should building codes or other types of 

public health regulation or legislation be 

used to help prevent Legionnaires’ 

disease? Why or why not? 

(9) Are there other approaches to 

reducing the risk of Legionnaires’ 

disease that your organization has found 

to be useful besides implementation of 

WMPs? 

(10) What additional considerations 

are relevant to developing guidance for 

preventing Legionnaires disease? 

(11) Has your organization 

implemented specific approaches to 

reducing the risk of disease due to other 

opportunistic waterborne pathogens 

besides Legionella? If so, please explain. 

Do these approaches conflict in any way 

with your approaches to reducing the 

risk of Legionnaires disease? 

Dated: August 15, 2017. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2017–17491 Filed 8–17–17; 8:45 am] 

BILLING CODE 4163–18–P 

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. 

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Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices 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); 

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39442 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices 

Frequency: Annually; Affected Public: 

Private Sector: Business or other forprofits 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4069] 

Bayer Healthcare Pharmaceuticals; 

Withdrawal of Approval of a New Drug 

Application for BAYCOL (cerivastatin 

sodium) Tablets, 0.05 Milligrams, 0.1 

Milligrams, 0.2 Milligrams, 0.3 

Milligrams, 0.4 Milligrams, and 0.8 

Milligrams 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of new drug application (NDA) 

020740 for BAYCOL (cerivastatin 

sodium) tablets, 0.05 milligrams (mg), 

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8 

mg, held by Bayer Healthcare 

Pharmaceuticals (Bayer). Bayer 

requested withdrawal of this 

application, and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of 

August 18, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Kristiana Brugger, Office of Regulatory 

Policy, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6262, Silver Spring, 

MD 20993, 301–796–3600. 

SUPPLEMENTARY INFORMATION: NDA 

020740 for BAYCOL (cerivastatin 

sodium) tablets, 0.05 mg, 0.1 mg, 0.2 

mg, and 0.3 mg, was received on June 

26, 1996, under section 505(b) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). FDA approved NDA 020740 

on June 26, 1997, as safe and effective 

as an adjunct to diet for the reduction 

of elevated total and LDL cholesterol 

levels in patients with primary 

hypercholesterolemia and mixed 

dyslipidemia (Frederickson Types IIa 

and IIb) when the response to dietary 

restriction of saturated fat and 

cholesterol and other nonpharmacological measures alone has 

been inadequate. Supplemental NDAs 

were received by FDA on July 17, 1998, 

for the 0.4 mg strength of the drug 

(approved on May 24, 1999) and on 

September 23, 1999, for the 0.8 mg 

strength of the drug (approved on July 

21, 2000). The most recently approved 

labeling (May 21, 2001) for this drug 

stated that: ‘‘BAYCOL® (cerivastatin 

sodium tablets) is indicated as an 

adjunct to diet to reduce elevated 

Total–C, LDL–C, apo B, and TG and to 

increase HDL–C levels in patients with 

primary hypercholesterolemia and 

mixed dyslipidemia (Fredrickson Types 

IIa and IIb) when the response to dietary 

restriction of saturated fat and 

cholesterol and other nonpharmacological measures alone has 

been inadequate.’’ 

Over time, however, reports 

associating cerivastatin with 

rhabdomyolysis, a potentially fatal 

condition involving muscle weakness, 

increased. Because of these reports, 

Bayer withdrew BAYCOL from the 

market on August 8, 2001. On January 

24, 2014, Bayer wrote to FDA asking the 

Agency to withdraw approval of NDA 

020740 under 21 CFR 314.150(d) and 

waived its opportunity for a hearing. 

Accordingly, under section 505(e) of 

the FD&C Act (21 U.S.C. 355(e)) and 

section 314.150(d), approval of NDA 

020740, and all amendments and 

supplements thereto, is withdrawn. 

Distribution of BAYCOL (cerivastatin 

sodium) tablets, 0.05 mg, 0.1 mg, 0.2 

mg, 0.3 mg, 0.4 mg, and 0.8 mg in 

interstate commerce without an 

approved application is illegal and 

subject to regulatory action (see sections 

505(a) and 301(d) of the FD&C Act (21 

U.S.C. 355(a) and 331(d)). 

Dated: August 15, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17510 Filed 8–17–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Mental Health Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Mental Health Council. 

Date: September 14, 2017. 

Open: 9:00 a.m. to 12:45 p.m. 

Agenda: Presentation of the NIMH 

Director’s Report and discussion. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Closed: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Jean G. Noronha, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Mental Health, NIH 

Neuroscience Center, 6001 Executive Blvd., 

Room 6154, MSC 9609, Bethesda, MD 20892– 

9609, 301–443–3367, jnoronha@mail.nih.gov. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml., where an 

agenda and any additional information for 

the meeting will be posted when available. 

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