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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

63134 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 

Dated: October 16, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–25030 Filed 10–21–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings 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 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Ancillary Studies: 

Group 1, Diabetes. 

Date: December 3, 2014. 

Time: 1:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Paul A. Rushing, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 747, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8895, 

rushingp@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; U.S.-India Bilateral 

Collaborative Research Partnerships (CRP) on 

Diabetes Research (R21). 

Date: January 26, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Najma Begum, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 749, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS). 

Dated: October 16, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–25045 Filed 10–21–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following 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 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group, Acquired Immunodeficiency 

Syndrome Research Review Committee. 

Date: November 18, 2014. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3E70B, 5601 Fishers Lane, Bethesda, MD 

20892, (Telephone Conference Call). 

Contact Person: Vasundhara Varthakavi, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, NIH/NIAID/DEA/ARRB, 

5601 Fishers Lane, Bethesda, MD 20892, 

240–669–5010, varthakaviv@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS). 

Dated: October 16, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–25042 Filed 10–21–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute Meeting 

ACTION: Notice of meeting. 

SUMMARY: Pursuant to the NIH Reform 

Act of 2006 (42 U.S.C. 281(d)(4)), notice 

is hereby given that the National Eye 

Institute will host a meeting to enable 

public discussion of the Institute’s 

proposal to rename its Division of 

Extramural Research to the Division of 

Extramural Science and establish a new 

Division of Extramural Activities. The 

proposal seeks to clearly delineate 

functions and streamline the services 

provided by adding focus to scientific 

programs and extramural operations. 

This proposed change aligns NEI with 

the structure of other NIH Institutes and 

Centers. 

DATES: The public hearing will be 

available to view on October 23, 2014. 

ADDRESSES: The public hearing will be 

recorded at the National Eye Institute, 

31 Center Drive, Bethesda, MD 20892. 

To comment or ask a question about the 

reorganization, please send an email to 

the following address: 

NEIOrgChangeComment@mail.nih.gov. 

To view the webinar, which will be 

posted on YouTube on October 23, 

2014, go to the following Web site: 

www.nei.nih.gov/DEROrgChange. 

FOR FURTHER INFORMATION CONTACT: 

Aytaj Vily, National Eye Institute, NIH, 

MPAB, 31 Center Drive, Bethesda, MD 

20892, at NEIOrgChangeComment@

mail.nih.gov. 

Members of the public wishing to 

have their questions or comments 

addressed related to this presentation on 

the reorganization need to send them to 

the following email address: 

NEIOrgChangeComment@mail.nih.gov. 

Individuals will be able to watch the 

presentation via a YouTube webinar. 

Please go to the following link to view 

the webinar: www.nei.nih.gov/

DEROrgChange. 

Any interested person may file 

written comments by sending an email 

to the following email address: 

NEIOrgChangeComment@mail.nih.gov, 

by October 30, 2014. The statement 

should include the individual’s name 

and, when applicable, professional 

affiliation. Responses will be sent by 

November 4, 2014. 

SUPPLEMENTARY INFORMATION: The 

agenda of the public meeting will enable 

public discussion on the proposed 

reorganization plans for NEI. This 

meeting will be in the form of a webinar 

posted on YouTube on October 23, 

mstockstill on DSK4VPTVN1PROD with NOTICES