Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 12973 

Name of Committees: 

Nonprescription Drugs Advisory 

Committee and the Pediatric Advisory 

Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 17, 2011, from 8 a.m. to 5 

p.m. and on May 18, 2011, from 8 a.m. 

to 12 noon. 

ADDRESSES: FDA is opening a docket for 

public comment on this meeting. The 

docket number is FDA–2011–N–0002. 

The docket will open for public 

comment on March 9, 2011. The docket 

will close on June 30, 2011. Interested 

persons may submit electronic or 

written comments regarding this 

meeting. Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments received will be posted 

without change, including any personal 

information provided. Submit a single 

copy of electronic comments or a paper 

copy of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this meeting 

notice. Received comments may be seen 

in the Division of Dockets Management 

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

through Friday. Comments received on 

or before May 3, 2011, will be provided 

to the committee before the meeting. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Diem-Kieu Ngo, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO31–2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301– 

847–8533, e-mail: 

diem.ngo@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On May 17 and 18, 2011, the 

committees will review pertinent 

pharmacokinetic (how drugs are 

absorbed, distributed, used, and 

eliminated by the body), safety and 

efficacy data, and discuss whether new 

dosing information for oral over-thecounter (OTC) drug products containing 

acetaminophen should be added to the 

label for children less than 2 years of 

age. In addition, the committees will 

consider adding a weight-based dosing 

regimen to the existing age-based dosing 

regimen for children 2 to 12 years of 

age. Dosing for children 12 years of age 

and older will not be discussed. Lastly, 

the committees will discuss ways that 

administration by caregivers can be 

improved so that medication errors can 

be minimized. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section of 

this document) on or before May 3, 

2011, will be provided to the 

committees. Oral presentations from the 

public will be scheduled between 

approximately 3 p.m. and 5 p.m. on 

May 17, 2011. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 25, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 26, 2011. 

FDA will work with sponsors of 

acetaminophen products who wish to 

make presentations to ensure that 

adequate time, separate from the 3 p.m. 

to 5 p.m. time slots for the general open 

public hearing, is provided. Sponsors 

interested in making formal 

presentations to the committees should 

notify the contact person on or before 

April 25, 2011. Sponsors with common 

interest are urged to coordinate their 

oral presentations. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Diem-Kieu 

Ngo at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5284 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the 

Neurological Devices Panel of the 

Medical Devices Advisory Committee. 

This meeting was announced in the 

Federal Register of February 7, 2011 (76 

FR 6625). The amendment is being 


Emcdonald on DSK2BSOYB1PROD with NOTICES
12974 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 

made to reflect a change in the Agenda 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: Olga 

I. Claudio, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1611, Silver Spring, 

MD 20993–0002, 301–796–7608, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 

Information Line for up-to-date 

information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 7, 2011, 

FDA announced that a meeting of the 

Neurological Devices Panel of the 

Medical Devices Advisory Committee 

would be held on March 17 and 18, 

2011. On page 6625, in the second 

column, in the last paragraph, in the 

first and second sentences, the ‘‘for the 

NovoTTF–100A Treatment Kit, 

sponsored by Hogan Lovells US LLP for 

NovoCure, Ltd. The NovoTTF–100A 

Treatment Kit’’ portion of the document 

is changed to read as follows: ‘‘for the 

NovoTTF–100A System, sponsored by 

NovoCure, Ltd. The NovoTTF–100A 

System’’. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: March 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5285 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–E–0483 and FDA– 

2010–E–0484] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AMPYRA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

AMPYRA and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of patents 

which claim that human drug product. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these Acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product AMPYRA 

(dalfampridine). AMPYRA is indicated 

to improve walking in patients with 

multiple sclerosis. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for AMPYRA (U.S. Patent 

Nos. 5,370,879 and 5,540,938) from Elan 

Pharma International Ltd., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining the 

patents’ eligibility for patent term 

restoration. In a letter dated September 

30, 2010, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

AMPYRA represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the Patent 

and Trademark Office requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

AMPYRA is 9,845 days. Of this time, 

9,569 days occurred during the testing 

phase of the regulatory review period, 

while 276 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: 

February 10, 1983. The applicant claims 

January 1, 1980, as the date the 

investigational new drug application 

(IND) became effective. However, FDA 

records indicate that the IND was 

initially placed on clinical hold. The 

applicant was informed that the 

investigational studies were allowed to 

proceed on February 10, 1983, the 

effective date of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: April 22, 2009. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

AMPYRA (NDA 22–250) was submitted 

on April 22, 2009. 

3. The date the application was 

approved: January 22, 2010. FDA has 

verified the applicant’s claim that NDA 

22–250 was approved on January 22, 

2010. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 1,827 and 1,826 

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 May 9, 2011. 

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 

September 5, 2011. To meet its burden, 

the petition must contain sufficient facts 


Emcdonald on DSK2BSOYB1PROD with NOTICES