Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 20643 

June 1, 2012. 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 June 4, 2012. 

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 Ann Marie 

Williams, at 

AnnMarie.Williams@fda.hhs.gov or 

301–796–5966, 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/Advisory

Committees/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 30, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–8166 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Blood Products 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 15, 2012, from 8:30 a.m. to 

5 p.m. and May 16, 2012 from 8 a.m. to 

4 p.m. 

Location: Hilton Washington DC/ 

North Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877, 301–977–8900. 

For those unable to attend in person, the 

meeting will also be Web cast. The Web 

cast will be available at the following 

links. 

Blood Products Advisory Committee 

Web Cast Link 

May 15 

http://fda.yorkcast.com/webcast/

Viewer/?peid=ba104b31fe4c4c0995

68bacda9a4e5401d. 

May 16 

http://fda.yorkcast.com/webcast/ 

Viewer/?peid=19caf3c8c1624acdaab

205ddde9c48581d. 

Contact Person: Bryan Emery or 

Rosanna Harvey, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–1297, 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 15, 2012, the 

committee will discuss as a device 

panel the evaluation of the safety and 

effectiveness of the OraQuick In-Home 

HIV Test. On May 16, 2012, the 

committee will discuss the evaluation of 

possible new plasma products frozen 

following in-process storage at room 

temperature for up to 24 hours, namely 

plasma for transfusion prepared from 

Whole Blood held at room temperature 

for up to 24 hours prior to separation 

and freezing, or from apheresis plasma 

held at room temperature for up to 24 

hours before freezing. In the afternoon, 

the committee will hear update 

presentations on the following topics: 

HHS activities related to the evaluation 

of the donor deferral policy for men 

who have had sex with other men; a 

summary of the November 8–9, 2011, 

public workshop on hemoglobin 

standards and maintaining an adequate 

blood supply; and a summary of the 

November 29, 2011, public workshop on 

data and data needs to advance risk 

assessment for emerging infectious 

diseases for blood and blood products. 

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. Written 

submissions may be made to the contact 

person on or before May 8, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1:30 

p.m. and 3:15 p.m. on May 15, 2012, 

and between approximately 11:30 a.m. 

and 12:45 p.m. on May 16, 2012. 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 30, 2012. 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 May 1, 2012. 

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 Bryan Emery, 

301–827–1277, or Rosanna Harvey, 301– 

827–1297, 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/Advisory


Tkelley on DSK3SPTVN1PROD with NOTICES
20644 Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 

Committees/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 30, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–8167 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0482] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; FLECTOR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

FLECTOR and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims 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 approved for marketing the 

human drug product FLECTOR 

(diclofenac epolamine). FLECTOR is 

indicated for the topical treatment of 

acute pain due to minor strains, sprains, 

and contusions. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for FLECTOR (U.S. Patent 

No. 5,607,690) from Altergon S.A., and 

Teikoku Seiyaku Co., Ltd., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration and that FDA determine the 

product’s regulatory review period. In a 

letter dated March 20, 2012, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of FLECTOR 

represented the first permitted 

commercial marketing or use of the 

product. 

FDA has determined that the 

applicable regulatory review period for 

FLECTOR is 4,031 days. Of this time, 

1,796 days occurred during the testing 

phase of the regulatory review period, 

while 2,235 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: January 

20, 1996. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on January 20, 

1996. 

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 19, 

2000. The applicant claims December 

18, 2000, as the date the new drug 

application (NDA) for FLECTOR (NDA 

21–344) was initially submitted. 

However, FDA records indicate that 

NDA 21–234 is the correct application 

number for FLECTOR, rather than NDA 

21–344. NDA 21–234 for FLECTOR was 

submitted on December 19, 2000. 

3. The date the application was 

approved: January 31, 2007. FDA has 

verified the applicant’s claim that 

FLECTOR (NDA 21–234) was approved 

on January 31, 2007. 

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 application for patent extension, 

this applicant seeks 1,825 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 4, 2012. 

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 2, 2012. 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 petitions. It is 

only necessary to send one set of 

comments. However, if you submit a 

written petition, you must submit three 

copies of the petition. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 

Dated: March 16, 2012. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2012–8235 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 


Tkelley on DSK3SPTVN1PROD with NOTICES