63132 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 

the appropriate device classification of 

blood establishment computer software 

(BECS) and accessories to BECS. Blood 

establishment computer software is 

currently subject to the premarket 

notification [510(k)] provisions of the 

Federal Food, Drug and Cosmetic Act. 

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 meeting 

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 November 25, 2014. 

On December 2, 2014, oral presentations 

from the public will be scheduled 

between approximately 1 p.m. to 2 p.m. 

On December 3, 2014, oral presentations 

from the public will be scheduled 

between approximately 10:30 a.m. to 11 

a.m. 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 November 18, 2014. 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 

November 19, 2014. 

FDA has opened a docket for the 

public who are interested in presenting 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. The docket number is FDA– 

2014–N–1617. The docket will close 

November 25, 2014. Interested persons 

are encouraged to use the docket to 

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. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday and 

will be posted to the docket at http://

www.regulations.gov. 

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 

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: October 16, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–25067 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2012–E–1242; FDA– 

2012–E–1243] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CARBON DIOXIDE LASER 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CARBON DIOXIDE LASER 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 the United States Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that food additive. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

petitions (two copies are required) and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Submit petitions electronically to 

http://www.regulations.gov at Docket 

No. FDA–2013–S–0610. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6257, 

Silver Spring, MD 20993–0002, 301– 

796–7900. 

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 food additives, 

the testing phase begins on the date 

when a major health or environmental 

effects test is begun and runs until a 

petition relying on the test and 

requesting the issuance of a regulation 

for use of the additive under section 409 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 348) is 

initially submitted to FDA. The 

approval phase begins on the date a 

petition requesting the issuance of a 

regulation for use of the additive under 

section 409 of the FD&C Act is initially 

received. The approval phase continues 

until the regulation for the additive 

becomes effective or until commercial 

marketing is permitted (21 CFR 60.22). 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO 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 food additive will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(1)(B). 

FDA has amended the food additive 

regulations to provide for the safe use of 

CARBON DIOXIDE LASER for etching 

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Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 63133 

information on the surface of fresh, 

intact citrus fruit for commercial 

marketing as specified in 21 CFR 

179.43. Subsequent to this approval, 

USPTO received patent term restoration 

applications for CARBON DIOXIDE 

LASER (U.S. Patent Nos. 5,660,747 and 

5,897,797) from Durant Wayland, Inc., 

and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated February 13, 2013, FDA 

advised the USPTO that this product 

had undergone a regulatory review 

period and that FDA’s granting of the 

food additive petition for CARBON 

DIOXIDE LASER 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 

CARBON DIOXIDE LASER is 1,950 

days. The applicant has not asserted a 

testing phase. All 1,950 days of the 

regulatory review period occurred 

during the approval phase. This period 

of time was derived from the following 

dates: 

1. The date a major health or 

environmental effects test on the food 

additive was initiated: No date claimed. 

The applicant has not asserted a testing 

period. 

2. The date the application was 

initially submitted with respect to the 

food additive under section 409 of the 

FD&C Act: February 9, 2007. FDA has 

determined that the food additive 

petition (FAP) for Carbon Dioxide Laser 

for Etching Food (FAP 7M4768) was 

submitted on February 9, 2007. 

3. The date a regulation for use of the 

food additive became effective: June 11, 

2012. FDA has verified the applicant’s 

claim that FAP 7M4768 was granted 

through FDA’s issuance of a responsive 

food additive regulation, effective June 

11, 2012. 

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 applications for patent extension, 

this applicant seeks 5 years 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 December 22, 

2014. 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 April 20, 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: October 16, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25032 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, Program on 

Biosecurity and Biosafety Policy; 

Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of the meeting of the 

National Science Advisory Board for 

Biosecurity (NSABB). 

Name of Committee: National Science 

Advisory Board for Biosecurity. 

Date: October 22, 2014. 

Time: 8:00 a.m.–4:00 p.m. Eastern Time 

(Times are approximate and subject to 

change). 

Agenda: Presentations and discussions 

regarding: (1) Overview of recent Federal 

policies regarding biosafety and biosecurity; 

and (2) other business of the Board. 

Place: National Institutes of Health, 

Building 31; 6th Floor, Conference Room 6, 

Bethesda, Maryland. 

Contact Person: Carolyn Mosby, NSABB 

Program Assistant, NIH Program on 

Biosecurity and Biosafety Policy, 6705 

Rockledge Drive, Suite 750, Bethesda, 

Maryland 20892, (301) 435–5504, 

carolyn.mosby@nih.gov. 

Under authority 42 U.S.C. 217a, Section 

222 of the Public Health Service Act, as 

amended, the Department of Health and 

Human Services established the NSABB to 

provide advice regarding federal oversight of 

dual use research, defined as biological 

research that generates information and 

technologies that could be misused to pose 

a biological threat to public health and/or 

national security. 

The meeting will be open to the public, 

however pre-registration is strongly 

recommended due to space limitations. 

Persons planning to attend may register 

online at: http://palladianpartners.cvent.

com/d/KY8f5UlwH0WnoisQD81oFg/8nfg/P1/ 

1Q or by calling Palladian Partners, Inc. 

(Contact: Joel Yaccarino at 301–650–8660). 

Online registration will close at 12:00 p.m. 

Eastern the day before the meeting. After that 

time, you will need to register onsite on the 

day of the meeting, from 7:15 a.m. Eastern. 

Individuals who plan to attend and need 

special assistance, such as sign language 

interpretation or other reasonable 

accommodations, should indicate these 

requirements upon registration. 

This meeting will also be webcast. To 

access the webcast and meeting information, 

including the draft meeting agenda and the 

registration link, connect to: http://osp.od.

nih.gov/office-biotechnology-activities/

biosecurity/nsabb/nsabb-meetings-andconferences. Please check this site for 

updates. 

Time will be allotted on the agenda for oral 

public comment, with presentations limited 

to three minutes per speaker. Sign-up for oral 

public comments will begin at approximately 

7:45 a.m. on October 22, 2014, and will be 

restricted to one sign-in per person. In the 

event that time does not allow for all those 

interested to present oral comments, 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 

addition, any interested person may submit 

written comments to the NSABB prior to the 

meeting by sending the comments to the 

Contact Person listed on this notice by 5:00 

p.m. Eastern on October 20, 2014. Written 

comments should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. Any written comments 

received after the deadline will be provided 

to the Committee either before or after the 

meeting, depending on the volume of 

comments received and the time required to 

process them in accordance with privacy 

regulations and other applicable Federal 

policies. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxis, 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. 

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