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
5468 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 

Workshop objectives will include 

discussion and identification of 

promising innovations that could 

facilitate successful trials in OA, new 

approaches to recruitment for clinical 

trials, feasible and clinically meaningful 

trial endpoints, and approaches for 

reducing the time and cost of OA trials 

while maximizing the likelihood of 

success. 

Registration: There is no fee to attend 

the workshop, but attendees must 

register in advance. Space is very 

limited. Persons interested in attending 

this workshop may request to register by 

sending their resume and inquiry to 

AFScience@arthritis.org. The 

registration deadline is February 2, 

2016. 

II. Accommodations 

An online registration link and a 

meeting code will be provided through 

the registration process giving 

participants a reduced group rate for 

hotel accomodations, not including 

applicable taxes. No additional 

reservations are required. Industry and 

government attendees are responsible 

for the cost of their own accomodations. 

If you need special accommodations 

due to a disability, please contact Becky 

Bosworth at bbosworth@arthritis.org at 

least 7 days in advance. 

III. Transcripts 

No transcripts will be available from 

the event, however, the event will be 

video taped for the purposes of the 

Arthritis Foundation. Speaker 

presentation materials, if permitted by 

the presenter, will be available on the 

Arthritis Foundation Web site following 

the workshop. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01789 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–0145] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Improving Food Safety and Defense 

Capacity of the State and Local Level: 

Review of State and Local Capacities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Improving Food Safety and Defense 

Capacity of the State and Local Level: 

Review of State and Local Capacities’’ 

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 

November 30, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Improving Food 

Safety and Defense Capacity of the State 

and Local Level: Review of State and 

Local Capacities’’ 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 0910–0726. The 

approval expires on January 31, 2019. 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. 2016–01785 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–0275] 

Regulatory Site Visit Training Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation for 

participation in its Regulatory Site Visit 

Training Program (RSVP). This training 

program is intended to give CBER 

regulatory review, compliance, and 

other relevant staff an opportunity to 

visit biologics facilities. These visits are 

intended to allow CBER staff to directly 

observe routine manufacturing practices 

and to give CBER staff a better 

understanding of the biologics industry, 

including its challenges and operations. 

The purpose of this document is to 

invite biologics facilities to contact 

CBER for more information if they are 

interested in participating in this 

program. 

DATES: Submit either an electronic or 

written request for participation in this 

program by March 3, 2016. The request 

should include a description of your 

facility relative to products regulated by 

CBER. Please specify the physical 

address(es) of the site(s) you are 

offering. 

ADDRESSES: If your biologics facility is 

interested in offering a site visit, submit 

either an electronic request to http://

www.regulations.gov or a written 

request to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. If you 

previously responded to earlier requests 

to participate in this program and you 

continue to be interested in 

participating, please renew your request 

through a submission to the Division of 

Dockets Management. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Whitmarsh, Division of 

Manufacturers Assistance and Training, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G112, Silver Spring, 

MD 20993–0002, 240–402–8010, FAX: 

301–595–1243, email: 

Industry.Biologics@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products including blood and blood 

products, vaccines, and cellular, tissue, 

and gene therapies. CBER is committed 

to advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness, and availability 

of biological products to patients. To 

support this primary goal, CBER has 

initiated various training and 

development programs, including 

programs to further enhance 

performance of its compliance staff, 

regulatory review staff, and other 

relevant staff. CBER seeks to 

continuously enhance and update 

review efficiency and quality, and the 

quality of its regulatory efforts and 

interactions, by providing CBER staff 

with a better understanding of the 

biologics industry and its operations. 

Further, CBER seeks to enhance: (1) Its 

understanding of current industry 

practices and regulatory impacts and 

needs and (2) communication between 

CBER staff and industry. CBER initiated 

its RSVP in 2005. Through these annual 


wgreen on DSK2VPTVN1PROD with NOTICES