21248 Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices 

and/or amino acid supplementation 

alone. Subsequent to this approval, the 

USPTO received a patent term 

restoration application for RAVICTI 

(U.S. Patent No. 5,968,979) from 

Hyperion Therapeutics, Inc., and the 

USPTO requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

May 2, 2014, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of RAVICTI 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

RAVICTI is 2,126 days. Of this time, 

1,719 days occurred during the testing 

phase of the regulatory review period, 

while 407 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: April 

10, 2007. The applicant claims April 8, 

2006, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was April 10, 2007, 

when the IND was removed from 

clinical hold. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: December 23, 

2011. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for RAVICTI (NDA 203284) was 

submitted on December 23, 2011. 

3. The date the application was 

approved: February 1, 2013. FDA has 

verified the applicant’s claim that NDA 

203284 was approved on February 1, 

2013. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,450 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by June 16, 2015. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

October 14, 2015. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written or electronic 

petitions. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. If you submit a written 

petition, two copies are required. A 

petition submitted electronically must 

be submitted to http://

www.regulations.gov, Docket No. FDA– 

2013–S–0610. Comments and petitions 

that have not been made publicly 

available on http://www.regulations.gov 

may be viewed in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 14, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08845 Filed 4–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Addressing Inadequate Information on 

Important Health Factors in 

Pharmacoepidemiology Studies 

Relying on Healthcare Databases; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop, 

cosponsored by FDA and the University 

of Maryland Center for Excellence in 

Regulatory Science and Innovation, 

entitled ‘‘Methodological 

Considerations to Address Unmeasured 

Information About Important Health 

Factors in Pharmacoepidemiology 

Studies that Rely on Electronic 

Healthcare Databases to Evaluate the 

Safety of Regulated Pharmaceutical 

Products in the Postapproval Setting.’’ 

The purpose of the public workshop is 

to engage in constructive dialogue 

among regulators, academicians, 

pharmaceutical industry, clinicians, 

other stakeholders and the general 

public on potential strategies to improve 

availability of information on important 

health factors in pharmacoepidemiology 

studies that rely on electronic 

healthcare databases to evaluate the 

safety of pharmaceutical products in the 

postapproval setting. Electronic 

healthcare databases are increasingly 

being used in the postapproval 

assessment of the safety profile of 

pharmaceutical drug products. 

Date and Time: The public workshop 

will be held on May 4, 2015, 8 a.m. to 

5 p.m. 

Location: The public workshop will 

be held at FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Contact Person: Leslie Wheelock, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 4345, 

Silver Spring, MD, 301–796–4580, FAX: 

301–847–8106, leslie.wheelock@

fda.hhs.gov. 

Registration: Submit your online 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) by April 30, 

2015, at: http://

www.pharmacy.umaryland.edu/centers/

cersievents/biasinbigdata/. There is no 

registration fee for University of 

Maryland faculty, students, and staff, 

University of Maryland Center for 

Excellence in Regulatory Science and 

Innovation Industrial Consortia 

Members, and Federal Government 

employees. There is a $50.00 

registration fee for all other participants. 

Early registration is recommended 

because seating is limited. There will be 

no onsite registration. 

If you need special accommodations 

due to a disability, please contact Leslie 

Wheelock (see Contact Person) at least 

7 days in advance. 

SUPPLEMENTARY INFORMATION: 

In many instances, these resources 

allow for the timely evaluation of drugrelated adverse events since data on 

healthcare utilized by a large number of 

individuals are readily available. 

However, because these data are 

typically collected for administrative 

purposes, information on important 

health factors necessary to evaluate 

drug-outcome relationship may be 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices 21249 

absent or incomplete in these data 

sources. Examples include tobacco/

smoking use and history, alcohol 

consumption, weight and height, patient 

and family medical history, or use of 

over-the-counter medications. 

Incomplete capture or the absence of 

this information can result in biased or 

uncertain estimates for the drugoutcome relationship of interest leading 

to inadequate evaluation of the safety 

profile of prescription drug products. 

Webcast: Please be advised that as 

soon as possible after a Webcast of the 

public workshop is available, it will be 

accessible at: http://www.fda.gov/

ScienceResearch/SpecialTopics/

RegulatoryScience/ucm429136.htm. 

Dated: April 13, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08846 Filed 4–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council on Drug 

Abuse. 

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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council on Drug Abuse. 

Date: May 5–6, 2015. 

Closed: May 5, 2015, 1:00 p.m. to 3:00 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. 

Open: May 6, 2015, 8:30 a.m. to 2:00 p.m. 

Agenda: This portion of the meeting will 

be open to the public for announcements and 

reports of administrative, legislative, and 

program developments in the drug abuse 

field. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Susan R.B. Weiss, Ph.D., 

Director, Division of Extramural Research, 

Office of the Director, National Institute on 

Drug Abuse, NIH, DHHS, 6001 Executive 

Boulevard, NSC, Room 5274, MSC 9591, 

Rockville, MD 20892, 301–443–6487, 

sweiss@nida.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.drugabuse.gov/NACDA/

NACDAHome.html where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: April 13, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–08800 Filed 4–16–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council for Nursing 

Research. 

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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Nursing Research. 

Date: May 19–20, 2015. 

Open: May 19, 2015, 1:00 p.m. to 5:00 p.m. 

Agenda: Discussion of Program Policies 

and Issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, 6th Floor, C 

Wing, Room 6, Bethesda, MD 20892. 

Closed: May 20, 2015, 9:00 a.m. to 1:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, 6th Floor, C 

Wing, Room 6, Bethesda, MD 20892. 

Contact Person: Ann R. Knebel, DNSC, RN, 

FAAN, Deputy Director, National Institute of 

Nursing Research, National Institutes of 

Health, 31 Center Drive, Building 31, Room 

5B05, Bethesda, MD 20892, 301–496–8230, 

knebelar@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the 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. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: www.nih.gov/ 

ninr/a_advisory.html, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 


tkelley on DSK3SPTVN1PROD with NOTICES