53316 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 

improve glycemic control in adults with 

type 2 diabetes mellitus. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for ONGLYZA (U.S. Patent 

No. 6,395,767) from Bristol-Myers 

Squibb Co., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated March 3, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of ONGLYZA 

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 

ONGLYZA is 2,794 days. Of this time, 

2,397 days occurred during the testing 

phase of the regulatory review period, 

while 397 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 act) (21 U.S.C. 

355(i)) became effective: December 8, 

2001. The applicant claims November 8, 

2001, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 8, 

2001, which was 30 days after FDA 

receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: June 30, 2008. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

ONGLYZA (NDA 22–350) was 

submitted on June 30, 2008. 

3. The date the application was 

approved: July 31, 2009. FDA has 

verified the applicant’s claim that NDA 

22–350 was approved on July 31, 2009. 

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 896 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 November 1, 

2010. 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 [insert date 180 days after 

date of publication in the Federal 

Register]. 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. It is no longer necessary to 

send three copies of mailed 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: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–21583 Filed 8–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0431] 

Draft Guidance for Food and Drug 

Administration Staff and Tobacco 

Retailers on Civil Money Penalties and 

No-Tobacco-Sale Orders for Tobacco 

Retailers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Civil Money Penalties and No-TobaccoSale Orders for Tobacco Retailers.’’ This 

guidance document is intended to 

describe FDA’s current policies with 

respect to civil money penalties and notobacco-sale orders for retailers who 

violate requirements of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) relating to tobacco products, 

including the FD&C Act requirement 

that tobacco products may not be sold 

or distributed in violation of FDA’s 

‘‘Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ When this guidance 

document is final, several provisions in 

the Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) that relate to civil money penalties 

and no-tobacco-sale orders will become 

effective. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 1, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Civil Money Penalties and No-TobaccoSale Orders for Tobacco Retailers’’ to the 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the guidance document may be 

sent. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit 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: 

Gerie A. Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for FDA Staff and 

tobacco retailers entitled ‘‘Civil Money 

Penalties and No-Tobacco-Sale Orders 

for Tobacco Retailers.’’ On June 22, 

2009, President Obama signed the 

Tobacco Control Act (Public Law 111– 

31) into law . The Tobacco Control Act 

grants FDA important new authority to 

regulate the manufacture, marketing and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Among its many provisions, the 

Tobacco Control Act authorizes FDA to 

impose civil money penalties for 

violations of FD&C Act requirements 

that relate to tobacco products (section 

303(f)(9) of the FD&C Act (21 U.S.C. 333 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 53317 

(f)(9)). Of special interest to retailers, 

one of the FD&C Act’s requirements is 

that tobacco products may not be sold 

or distributed in a manner that violates 

regulations issued under section 906(d) 

of the FD&C Act, such as the 

‘‘Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents’’ that were published by 

FDA in the Federal Register of March 

19, 2010 (75 FR 13225) (21 CFR part 

1140). The Tobacco Control Act also 

authorizes FDA to impose a no-tobaccosale order on a retail outlet for repeated 

violations of regulations issued under 

section 906(d) of the FD&C Act, and 

discusses a number of technical and 

procedural issues relating to civil 

money penalties and no-tobacco-sale 

orders. 

The draft guidance document 

describes the penalty structure and draft 

FDA policies with respect to civil 

money policies and no-tobacco-sale 

orders. When this guidance is final, 

several Tobacco Control Act provisions 

that relate to civil money penalties and 

no-tobacco-sale orders will become 

effective (section 103(q)(3) of the 

Tobacco Control Act). 

II. Significance of Guidance 

FDA is issuing this draft guidance 

document as a level 1 draft guidance 

consistent with FDA’s good guidance 

practices regulation (§ 10.115 (21 CFR 

10.115)). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on ‘‘Civil Money 

Penalties and No-Tobacco-Sale Orders 

for Tobacco Retailers.’’ It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (See 

ADDRESSES), electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/TobaccoProducts/ 

GuidanceCompliance

RegulatoryInformation/default.htm or 

http://www.regulations.gov. 

Dated: August 26, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–21661 Filed 8–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Alcohol. 

Date: September 29, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Michael Selmanoff, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3134, 

MSC 7844, Bethesda, MD 20892. 301–435– 

1119. mselmanoff@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group, 

Tumor Microenvironment Study Section. 

Date: October 4–5, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Ritz-Carlton, Washington, DC, 

1150 22nd Street, NW., Washington, DC, 

20037. 

Contact Person: Eun Ah Cho, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6202, 

MSC 7804, Bethesda, MD 20892. (301) 451– 

4467. choe@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group, Synthetic and Biological 

Chemistry A Study Section. 

Date: October 7–8, 2010. 

Time: 8 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Mike Radtke, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4176, 

MSC 7806, Bethesda, MD 20892. 301–435– 

1728. radtkem@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group, Neural Basis of Psychopathology, 

Addictions and Sleep Disorders Study 

Section. 

Date: October 7–8, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Washington, DC, 

1250 22nd Street, NW., Washington, DC 

20037. 

Contact Person: Boris P Sokolov, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217A, 

MSC 7846, Bethesda, MD 20892. 301–408– 

9115. bsokolov@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group, 

Cancer Etiology Study Section. 

Date: October 7–8, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marina del Rey Marriott, 4100 

Admiralty Way, Marina del Rey, CA 90292. 

Contact Person: Elaine Sierra-Rivera, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6184, 

MSC 7804, Bethesda, MD 20892. 301–435– 

1779. riverase@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group, 

Cancer Genetics Study Section. 

Date: October 7–8, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Washington, DC, 

1515 Rhode Island Avenue, NW., 

Washington, DC 20005. 

Contact Person: Steven F. Nothwehr, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5183, 

MSC 7840, Bethesda, MD 20892. 

301.408.9435. nothwehrs@mail.nih.gov. 

Name of Committee: Digestive, Kidney and 

Urological Systems Integrated Review Group, 

Pathobiology of Kidney Disease Study 

Section. 

Date: October 7, 2010. 

Time: 8 a.m. to 7 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Atul Sahai, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 


srobinson on DSKHWCL6B1PROD with NOTICES