Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5465 

ADDRESSES sections above and state 

whether or not they are in the 

community in which the hospital is 

located. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Dated: January 6, 2016. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2016–01830 Filed 2–1–16; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0662] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Applications for 

Food and Drug Administration 

Approval to Market a New Drug: Patent 

Submission and Listing Requirements 

and Application of 30-Month Stays on 

Approval of Abbreviated New Drug 

Applications Certifying That a Patent 

Claiming a Drug Is Valid or Will Not Be 

Infringed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 reporting requirements for 

submission and listing of patent 

information associated with a new drug 

application (NDA), an amendment, or a 

supplement. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 4, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

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 http://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): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, 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– 

2013–N–0662 for ‘‘Agency Information 

Collection Activities: Proposed 

Collection; Comment Request; 

Applications for Food and Drug 

Administration Approval to Market a 

New Drug: Patent Submission and 

Listing Requirements and Application 

of 30-Month Stays on Approval of 

Abbreviated New Drug Applications.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

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 http:// 

www.regulations.gov. Submit both 

copies to the Division of Dockets 

Management. 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: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 


wgreen on DSK2VPTVN1PROD with NOTICES
5466 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 

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. 

Applications for FDA Approval To 

Market a New Drug: Patent Submission 

and Listing Requirements and 

Application of 30-month Stays on 

Approval of Abbreviated New Drug 

Applications Certifying That a Patent 

Claiming a Drug Is Invalid or Will Not 

Be Infringed—OMB Control Number 

0910–0513—Extension 

Section 505(b)(1) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 355(b)(1)) requires all NDA 

applicants to file, as part of the NDA, 

‘‘the patent number and the expiration 

date of any patent which claims the 

drug for which the applicant submitted 

the application or which claims a 

method of using such drug and with 

respect to which a claim of patent 

infringement could reasonably be 

asserted if a person not licensed by the 

owner engaged in the manufacture, use, 

or sale of the drug.’’ Section 505(c)(2) of 

the FD&C Act (21 U.S.C. 355(c)(2)) 

imposes a similar patent submission 

obligation on holders of approved NDAs 

when the NDA holder could not have 

submitted the patent information with 

its application. Under § 505(b)(1) of the 

FD&C Act, we publish patent 

information after approval of an NDA 

application in the list entitled 

‘‘Approved Drug Products with 

Therapeutic Equivalence Evaluations’’ 

(the Orange Book). If patent information 

is submitted after NDA approval, 

§ 505(c)(2) of the FD&C Act directs us to 

publish the information upon its 

submission. 

FDA regulations at §§ 314.50(h) (21 

CFR 314.50(h)) and 314.53 (21 CFR 

314.53) clarify the types of patent 

information that must and must not be 

submitted to FDA as part of an NDA, an 

amendment, or a supplement, and 

require persons submitting an NDA, an 

amendment, or a supplement, or 

submitting information on a patent after 

NDA approval, to make a detailed 

patent declaration using Form FDA 

3542a and Form FDA 3542. 

The reporting burden for submitting 

an NDA, an amendment, or supplement 

in accordance with § 314.50 (a) through 

(f), and (k) has been estimated by FDA 

and the collection of information has 

been approved by OMB under OMB 

control number 0910–0001. We are not 

re-estimating these approved burdens in 

this document. Only the reporting 

burdens associated with patent 

submission and listing, as explained 

below, are estimated in this document. 

The information collection reporting 

requirements are as follows: 

Section 314.50(h) requires that an 

NDA, an amendment, or a supplement 

contain patent information described 

under § 314.53. 

Section 314.53 requires that an 

applicant submitting an NDA, an 

amendment, or a supplement, except as 

provided in § 314.53(d)(2), submit on 

Forms 3542 and 3542a, the required 

patent information described in this 

section. 

Compliance with the information 

collection burdens under §§ 314.50(h) 

and 314.53 consists of submitting with 

an NDA, an amendment, or a 

supplement (collectively referred to as 

‘‘application’’) the required patent 

declaration(s) on Form 3542a for each 

‘‘patent that claims the drug or a method 

of using the drug that is the subject of 

the new drug application or amendment 

or supplement to it and with respect to 

which a claim of patent infringement 

could reasonably be asserted if a person 

not licensed by the owner of the patent 

engaged in the manufacture, use, or sale 

of the drug product’’ (§ 314.53(b)). Such 

patents claim the drug substance (active 

ingredient), drug product (formulation 

and composition), or method of use. If 

a patent is issued after the application 

is filed with FDA, but before the 

application is approved, the applicant 

must submit the required patent 

information on Form 3542a as an 

amendment to the application, within 

30 days of the date of issuance of the 

patent. 

Within 30 days after the date of 

approval of an application, the 

applicant must submit Form 3542 for 

each patent that claims the drug 

substance (active ingredient), drug 

product (formulation and composition), 

or approved method of use for listing in 

the Orange Book. In addition, for 

patents issued after the date of approval 

of an application, Form 3542 must be 

submitted within 30 days of the date of 

issuance of the patent. 

FDA requests OMB approval for the 

following information collection: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 314.50 

(citing § 314.53) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Hours per 

response 

Total 

hours 

Form FDA 3542a ........................................................... 241 3.4 819 20 16,380 

Form FDA 3542 ............................................................. 200 3.4 680 5 3,400 

Total ........................................................................ ........................ ........................ ........................ ........................ 19,780 

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


wgreen on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5467 

The numbers of patents submitted to 

FDA for listing in the Orange Book in 

2012, 2013, and 2014 were 458, 509, 

and 617, respectively, for an annual 

average of 528 (458 patents + 509 

patents + 617 patents)/3 years = 528 

patents/year). Because many of these 

individual patents are included in 

multiple NDA submissions, there could 

be multiple declarations for a single 

patent. From our previous review of 

submissions, we believe that 

approximately 14 percent of the patents 

submitted are included in multiple NDA 

submissions, and thus require multiple 

patent declarations. Therefore, we 

estimate that 74 (528 patents × 14 

percent) patents will be multiple 

listings, and there will be a total of 602 

patents (528 patents + 74 patents = 602 

patents) declared on Form FDA 3542. 

We approved 86, 94, and 107 NDAs in 

calendar years 2012, 2013, and 2014, 

respectively, of which we estimate 

based on our previous review that 

approximately 71 percent submitted 

patent information for listing in the 

Orange Book. The remaining NDAs 

submitted Form FDA 3542 as required 

and declared that there were no relevant 

patents. We also approved 

approximately 101, 101, and 110 NDA 

supplements in FYs 2012, 2013, and 

2014, respectively, for which 

submission of a patent declaration 

would be required. We estimate there 

will be 200 instances (based on an 

average of 96 NDA approvals and 104 

supplement approvals per year) where 

an NDA holder would be affected by the 

patent declaration requirements, and 

that each of these NDA holders would, 

on average, submit 3.4 declarations (602 

patent declarations + 74 no relevant 

patent declarations)/200 instances = 3.4 

declarations per instance) on Form FDA 

3542. We filed 112, 116, and 113 NDAs 

in 2012, 2013, and 2014, respectively, 

and 112, 112, 156 NDA supplements in 

2012, 2013, and 2014, respectively, for 

which submission of a patent 

declaration would be required. We 

estimate there will be 241 instances 

(based on an average of 114 NDAs filed 

and 127 NDA supplements filed per 

year) where an NDA holder would be 

affected by the patent declaration 

requirements. We estimate, based on a 

proportional increase from the number 

of declarations for approved NDAs, that 

there will be an annual total of 819 

declarations (241 instances × 3.4 

declarations per instance = 819 

declarations) on Form FDA 3542a 

submitted with these applications. 

Based upon information provided by 

regulated entities and other information, 

we previously estimated that the 

information collection burden 

associated with § 314.50(h) (citing 

§ 314.53) and Forms FDA 3542 and 

3542a will be approximately 5 hours 

and 20 hours per response, respectively. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01782 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0129] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

General Licensing Provisions; Section 

351(k) Biosimilar Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘General Licensing Provisions; Section 

351(k) Biosimilar Applications’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On July 8, 

2015, the Agency submitted a proposed 

collection of information entitled 

‘‘General Licensing Provisions; Section 

351(k) Biosimilar Applications’’ to OMB 

for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0719. The 

approval expires on December 31, 2018. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://

www.reginfo.gov/public/do/PRAMain. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01783 Filed 2–1–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0001] 

The Arthritis Foundation—Food and 

Drug Administration Accelerating 

Osteoarthritis Clinical Trials Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of workshop. 

SUMMARY: Osteoarthritis is the most 

common form of arthritis, and occurs 

when the cartilage that cushions the 

bones of the joint break down and the 

bones begin to rub together. This can 

cause pain, swelling, and loss of motion 

of the joint. The Food and Drug 

Administration’s (FDA) Center for Drug 

Evaluation and Research, in cosponsorship with the Arthritis 

Foundation is announcing a workshop 

entitled, ‘‘Accelerating OA Clinical 

Trials Workshop’’. The purpose of the 

workshop is to discuss 

recommendations from the international 

Arthritis Foundation Accelerating 

Osteoarthritis Clinical Trial workgroup 

and identify next steps in forging new 

approaches to osteoarthritis clinical 

trials that may improve the likelihood of 

successful conduct and outcomes of 

these trials and lead to the development 

of safe and effective treatments for 

osteoarthritis. 

DATES: The workshop will be held on 

February 24, 2016, from 8 a.m. to 5:30 

p.m., and February 25, 2016, from 8 a.m. 

to 2 p.m. 

ADDRESSES: The workshop will be held 

at the Atlanta Airport Hilton, 1031 

Virginia Ave., Atlanta, GA 30354. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Yim, Office of New Drugs, Center 

for Drug Evaluation and Research, 

email: sarah.yim@fda.hhs.gov; Amanda 

Niskar, Arthritis Foundation, Inc., 1330 

West Peachtree St., Atlanta, GA 30309, 

404–964–7545, FAX: 404–965–7807, 

email: aniskar@arthritis.org; or Becky 

Bosworth, Arthritis Foundation, Inc., 

1330 West Peachtree St., Atlanta, GA 

30309, 404–965–7673, email: 

bbosworth@arthritis.org. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The osteoarthritis (OA) community of 

clinicians, physicians and scientists 

have been challenged to get new 

treatments to market so that people with 

OA can benefit at the point of care. The 

Arthritis Foundation and FDA are 

convening experts to discuss alternative 

approaches to clinical trials in OA. 


wgreen on DSK2VPTVN1PROD with NOTICES