31152 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 

respondent for the MAQI demonstration 

to be 15 hours, to match the hours listed 

in the equivalent QPP forms. Full detail 

of how these estimates were derived can 

be found in the forthcoming Calendar 

Year 2019 Proposed QPP rule. 

If Demonstration participants 

submitted information, but did not meet 

these conditions of the Demonstration, 

their participation in the Demonstration 

would not be terminated, but they 

would not receive the waivers from 

MIPS reporting requirements and 

payment adjustments. Therefore, unless 

they become QPs or are excluded from 

MIPS for other reasons, the participating 

clinicians would be subject to MIPS and 

would face the MIPS payment 

adjustments for the applicable year. We 

are requesting approval of 2 information 

collections associated with the MAQI 

Demonstration: (a) A Qualifying 

Payment Arrangement Submission Form 

and (b) a Threshold Data Submission 

Form. Form Number: CMS–10673 (OMB 

control number: 0938–NEW); 

Frequency: Annually; Affected Public: 

Private sector—Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 100,000; Total 

Annual Responses: 100,000; Total 

Annual Hours: 1,500,000. (For policy 

questions regarding this collection 

contact John Amoh at john.amoh@

cms.hhs.gov.) 

Dated: June 28, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–14336 Filed 6–29–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2012–N–0129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; General Licensing 

Provisions; Section 351(k) Biosimilar 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

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 of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection in an application for a 

proposed biosimilar product and an 

application for a supplement for a 

proposed interchangeable product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 4, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 4, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 4, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 2012– 

N–0129 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; General 

Licensing Provisions; Section 351(k) 

Biosimilar Applications.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 31153 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

General Licensing Provisions; Section 

351(k) Biosimilar Applications 

OMB Control Number 0910–0719— 

Extension 

The Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) 

amended the Public Health Service Act 

(PHS Act) and other statutes to create an 

abbreviated licensure pathway for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed reference product. 

Section 351(k) of the PHS Act (42 U.S.C. 

262(k)), added by the BPCI Act, sets 

forth the requirements for an 

application for a proposed biosimilar 

product and an application or a 

supplement for a proposed 

interchangeable product. Section 351(k) 

defines biosimilarity to mean that the 

biological product is highly similar to 

the reference product notwithstanding 

minor differences in clinically inactive 

components and that ‘‘there are no 

clinically meaningful differences 

between the biological product and the 

reference product in terms of the safety, 

purity, and potency of the product (see 

section 351(i)(2) of the PHS Act). A 

351(k) application must contain, among 

other things, information demonstrating 

that the biological product is biosimilar 

to a reference product based upon data 

derived from analytical studies, animal 

studies, and clinical studies, unless 

FDA determines, in its discretion, that 

certain studies are unnecessary in a 

351(k) application (see section 351(k)(2) 

of the PHS Act). To meet the standard 

for interchangeability, an applicant 

must provide sufficient information to 

demonstrate biosimilarity and also to 

demonstrate that the biological product 

can be expected to produce the same 

clinical result as the reference product 

in any given patient and, if the 

biological product is administered more 

than once to an individual, the risk in 

terms of safety or diminished efficacy of 

alternating or switching between the use 

of the biological product and the 

reference product is not greater than the 

risk of using the reference product 

without such alternation or switch (see 

section 351(k)(4) of the PHS Act). 

Interchangeable products may be 

substituted for the reference product 

without the intervention of the 

prescribing healthcare provider (see 

section 351(i)(3) of the PHS Act) In 

estimating the information collection 

burden for 351(k) biosimilar product 

applications and interchangeable 

product applications or supplements, 

we reviewed the number of 351(k) 

applications FDA has received in fiscal 

years 2015, 2016, and 2017, considered 

responses to a survey of biosimilar 

sponsors and applicants regarding 

projected future 351(k) submission 

volumes, as well as the collection of 

information regarding the general 

licensing provisions for biologics 

license applications under section 

351(a) of the PHS Act submitted to OMB 

(approved under OMB control number 

0910–0338). 

To submit an application seeking 

licensure of a proposed biosimilar 

product under sections 351(k)(2)(A)(i) 

and (iii) of the PHS Act, the estimated 

burden hours (FDA believes) would be 

approximately the same as noted under 

OMB control number 0910–0338 for a 

351(a) application—860 hours. The 

burden estimates for seeking licensure 

of a proposed biosimilar product that 

meets the standards for 

interchangeability under sections 

351(k)(2)(B) and (k)(4) would also be 

860 hours per application. FDA believes 

these estimates are appropriate for 

351(k) applications because the 

paperwork burden for a 351(k) 

application is expected to be 

comparable to the paperwork burden for 

a 351(a) application. 

In addition to the collection of 

information regarding the submission of 

a 351(k) application for a proposed 

biosimilar or interchangeable biological 

product, section 351(l) of the BPCI Act 

establishes procedures for identifying 

and resolving patent disputes involving 

applications submitted under section 

351(k) of the PHS Act. The burden 

estimate for the patent notification 

provisions under section 351(l)(6)(C) of 

the BPCI Act are included in table 1 and 

are based on the estimated number of 

351(k) applicants. Based on similar 

reporting requirements, FDA estimates 

this notification will take 2 hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

351(k) Applications 

(42 U.S.C. 262(k)) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

351(k)(2)(A)(i) and 351(k)(2)(A)(iii) Biosimilar Product Applications ........................................................................... 4 2.25 9 860 7,740 

351(k)(2)(B) and (k)(4) Interchangeable Product Applications or Supplements ....................................................... 2 1 2 860 1,720 


sradovich on DSK3GMQ082PROD with NOTICES
31154 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

351(k) Applications 

(42 U.S.C. 262(k)) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

351(l)(6)(C) Patent Infringement Notifications ..................... 4 2.25 9 2 18 

Total .............................................................................. ........................ ........................ ........................ ........................ 9,478 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, the estimated burden for 

the information collection reflects an 

overall increase in total hours and 

responses. We attribute this adjustment 

to an increase in the number of 

submissions received over the last few 

years and additional interest in the 

biosimilars program. 

Dated: June 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14265 Filed 7–2–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2490] 

Antimicrobial Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Antimicrobial Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

August 7, 2018, from 8:30 a.m. to 4 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–1073. 

The docket will close on August 6, 

2018. Submit either electronic or 

written comments on this public 

meeting by August 6, 2018. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before August 

6, 2018. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

August 6, 2018. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Comments received on or before July 

24, 2018, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. 

You may submit comments 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– 

2018–N–2490 for ‘‘Antimicrobial Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see the ADDRESSES section), 

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.’’ FDA 

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 be made publicly 

available, you can provide this 

information on the cover sheet and not 


sradovich on DSK3GMQ082PROD with NOTICES