Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 63131 

Date and Time: The public workshop 

will be held on February 5, 2015, from 

9 a.m. to 4 p.m. EST. 

Location: The public workshop will 

be held at the Washington Plaza Hotel, 

10 Thomas Circle NW., Washington, DC 

20005. For additional travel and hotel 

information, please refer to http://

events.SignUp4.com/sentinel2015. (FDA 

has verified the Web site addresses 

throughout this notice, but FDA is not 

responsible for subsequent changes to 

the Web sites after this document 

publishes in the Federal Register.) 

There will also be a live Webcast for 

those unable to attend the meeting in 

person (see Streaming Webcast of the 

Public Workshop). 

Contact Person: Carlos Bell, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6358, 

Silver Spring, MD 20993, 301–796– 

3714, FAX: 301–847–3529, email: 

SentinelInitiative@fda.hhs.gov. 

Registration: To attend the public 

workshop, you must register before 

February 5, 2015, by visiting http://

events.SignUp4.com/sentinel2015. You 

may also register for the live Webcast by 

visiting this Web page. There will be no 

onsite registration. When registering, 

please provide the following 

information: Your name, title, company 

or organization (if applicable), postal 

address, telephone number, and email 

address. Those without Internet access 

should contact Carlos Bell to register 

(see Contact Person). There is no 

registration fee for the public workshop. 

However, registration will be on a firstcome, first-served basis because seating 

is limited. Therefore, early registration 

is recommended. A 1-hour lunch break 

is scheduled, but food will not be 

provided. There are multiple restaurants 

within walking distance of the 

Washington Plaza Hotel. 

If you need special accommodations 

due to a disability, please contact 

Joanna Klatzman at the Brookings 

Institution (202–536–3634, email: 

SentinelEvent@Brookings.edu) at least 7 

days in advance. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be Webcast (archived video footage 

will be available on the Brookings 

Institution Web site following the 

workshop). Persons interested in 

viewing the live Webcast must register 

online by February 4, 2015, at 5 p.m. 

EST. Early registration is recommended 

because Webcast connections are 

limited. Organizations are requested to 

register all participants but to view 

using one connection per location 

whenever possible. Webcast 

participants will be sent technical 

system requirements and a test link in 

advance of the event. Prior to joining the 

streaming Webcast of the public 

workshop, it is recommended that you 

review these technical system 

requirements and test your connection. 

Meeting Materials: All event materials 

will be available to registered attendees 

via email before the workshop and will 

be posted after the event on the 

Brookings Institution event Web site at 

http://www.brookings.edu//health/

events. 

Transcripts: Please be advised that 

transcripts will not be available. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25053 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1617] 

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 December 2, 2014, from 8:30 

a.m. to 4:30 p.m. and December 3, 2014, 

from 8:30 a.m. to 12:30 p.m. 

ADDRESSES: FDA is opening a docket for 

person 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. Please see the procedure 

section of the notice for further 

information. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

For those unable to attend in person, 

the meeting will also be Web cast. The 

Web cast will be available at the 

following links: 

• December 2, 2014, Blood Products 

Advisory Committee Web link: 

https://collaboration.fda.gov/

bpac1214/ 

• December 3, 2014, Blood Products 

Advisory Committee Web link: 

https://collaboration.fda.gov/bpac

december3/ 

Contact Person: Bryan Emery or 

Joanne Lipkind, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, Bldg. 71, Rm. 6132, 240–402– 

8054 or 240–402–8106, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). 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 at 

http://www.fda.gov/

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: On December 2, 2014, the 

Committee will meet in open session to 

hear scientific data related to 

reconsideration of the current blood 

donor deferral policy for men who have 

had sex with another man (MSM) even 

one time since 1977. The Committee 

will be presented with an update on the 

November 13, 2014, meeting of the 

Advisory Committee on Blood and 

Tissue Safety and Availability where the 

MSM blood donor deferral policy will 

be discussed. In the afternoon, an 

informational presentation will be made 

regarding the emergence of chikungunya 

virus infections in the Western 

Hemisphere and potential implications 

for blood transfusion safety. The 

Committee will also hear an 

informational presentation on the first 

survey of the Rapid Donor Surveillance 

(RapidDOS) project on Middle Eastern 

Respiratory Syndrome coronavirus 

(MERS-CoV). 

On December 3, 2014, the Blood 

Products Advisory Committee will be 

seated as a device classification panel. 

In open session, the panel will discuss 

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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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