61762 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 

Bard’s tunneled home drainage catheter 

systems business and BD’s soft tissue 

core needle biopsy devices business to 

Merit. The provisions of the Consent 

Agreement will enable Merit to become 

an independent, viable, and effective 

competitor in the respective relevant 

markets and maintain the competition 

that currently exists. 

Merit, headquartered in South Jordan, 

Utah, is a global company with 30 years 

of experience in the development, 

manufacture, and distribution of 

medical devices used in interventional, 

diagnostic, and therapeutic procedures. 

Merit offers a portfolio of products that 

is highly complementary to the 

tunneled home drainage catheter 

systems being acquired. Merit also 

recently introduced its first soft tissue 

core needle biopsy device product. 

Merit possesses substantial industry 

expertise in these product areas and 

sells its products to similar customers as 

BD and Bard. For these reasons, Merit 

is well positioned to restore the benefits 

of competition that would be lost due to 

the Acquisition. 

Pursuant to the Order, Merit will 

receive all rights and assets related to 

Bard’s tunneled home drainage catheter 

system business and BD’s soft tissue 

core needle biopsy device business, 

including all of the confidential 

business information used in those 

businesses. Merit will own or receive a 

license to all intellectual property 

necessary to run the businesses. It will 

also acquire the equipment used in the 

manufacturing of the products and all 

documentation and other information 

related to the products. Respondents 

will also contract manufacture products 

for Merit until it is able to manufacture 

them itself, and Respondents will 

provide transitional services to Merit to 

assist the company in establishing 

manufacturing capabilities for the 

divested products. 

The Respondents must accomplish 

the divestitures no later than 10 days 

after the consummation of the proposed 

Acquisition. If the Commission 

determines that Merit is not an 

acceptable acquirer, or that the manner 

of the divestitures is not acceptable, the 

proposed Order requires the 

Respondents to unwind the sale of 

assets to Merit and then divest the assets 

to a Commission-approved acquirer(s) 

within 180 days of the date the Order 

becomes final. Pursuant to the Order To 

Maintain Assets, Respondents must 

maintain the businesses pending 

divestiture. 

The Commission has agreed to 

appoint a Monitor to ensure that the 

Respondents comply with all of their 

obligations pursuant to the Consent 

Agreement and to keep the Commission 

informed about the status of the transfer 

of assets to Merit. The Commission has 

appointed Mazars LLP as the Monitor in 

this matter. The proposed Order further 

allows the Commission to appoint a 

trustee in the event the parties fail to 

divest the products as required. 

VII. Opportunity for Public Comment 

The purpose of this analysis is to 

facilitate public comment on the 

Consent Agreement to aid the 

Commission in determining whether it 

should make the Order final. This 

analysis is not intended to constitute an 

official interpretation of the proposed 

Consent Agreement and does not 

modify its terms in any way. 

By direction of the Commission. 

April J. Tabor, 

Acting Secretary. 

[FR Doc. 2017–28213 Filed 12–28–17; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–262] 

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 January 29, 2018. 

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’ website address at 

https://www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Contract Year 

2019 Plan Benefit Package (PBP) 

Software and Formulary Submission; 

Use: We require that Medicare 


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Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 61763 

Advantage and Prescription Drug Plan 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to us for 

review and approval. We publish 

beneficiary education information using 

a variety of formats. The specific 

education initiatives that utilize PBP 

and formulary data include web 

application tools on www.medicare.gov 

and the plan benefit insert in the 

Medicare & You handbook. In addition, 

organizations utilize the PBP data to 

generate their Summary of Benefits 

marketing information. 

This notice replaces the 30-day 

Federal Register notice that published 

on December 13, 2017 (82 FR 58613) 

which was subsequently withdrawn on 

December 22, 2017 (82 FR 60744). 

Form Number: CMS–R–262 (OMB 

control number 0938–0763); Frequency: 

Yearly; Affected Public: Private sector 

(Business or other for-profits and Notfor-profit institutions); Number of 

Respondents: 520; Total Annual 

Responses: 5,675; Total Annual Hours: 

56,450. (For policy questions regarding 

this collection contact Kristy Holtje at 

410–786–2209.) 

Dated: December 26, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–28159 Filed 12–28–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6530] 

Formal Meetings Between the Food 

and Drug Administration and Sponsors 

or Applicants of Prescription Drug 

User Fee Act Products; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products.’’ This draft guidance provides 

recommendations to industry on formal 

meetings between FDA and sponsors or 

applicants relating to the development 

and review of drug or biological 

products (hereafter referred to as 

products). The previous guidance for 

industry ‘‘Formal Meetings Between the 

FDA and Sponsors or Applicants’’ 

published May 19, 2009, and the draft 

guidance for industry ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants of PDUFA Products’’ 

published March 11, 2015, have been 

withdrawn. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 29, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6530 for ‘‘Formal Meetings 

Between the Food and Drug 

Administration and Sponsors or 

Applicants of Prescription Drug User 

Fee Act Products; Draft Guidance for 

Industry; Availability.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 


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