Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 78715 

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 ANGIOMAX 

(bivalirudin). ANGIOMAX is indicated 

for use as an anticoagulant in patients 

with unstable angina undergoing 

percutaneous transluminal coronary 

angioplasty. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for ANGIOMAX (U.S. Patent 

No. 5,196,404) from The Medicines 

Company, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated September 6, 2001, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period, 

that the approval of ANGIOMAX 

represented the first permitted 

commercial marketing or use of the 

product, and that the patent term 

restoration application was untimely 

within the meaning of 35 U.S.C. section 

156(d)(1). 

On August 3, 2010, in The Medicines 

Company v. David Kappos et al., Civil 

Action No. 01:10-cv-286, the United 

States District Court for the Eastern 

District of Virginia, Alexandria Division, 

ordered the United States Patent and 

Trademark Office to consider The 

Medicines Company’s patent term 

restoration application for ANGIOMAX 

to have been timely filed. 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 

ANGIOMAX is 3,665 days. Of this time, 

2,576 days occurred during the testing 

phase of the regulatory review period, 

while 1,089 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: 

December 5, 1990. The applicant claims 

November 2, 1990, as the date the 

investigational new drug application 

(IND) became effective. However, FDA 

records indicate that the IND effective 

date was December 5, 1990, 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 FD&C Act: December 23, 

1997. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for ANGIOMAX (NDA 20–873) 

was submitted on December 23, 1997. 

3. The date the application was 

approved: December 15, 2000. FDA has 

verified the applicant’s claim that NDA 

20–873 was approved on December 15, 

2000. 

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 1,773 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 February 14, 

2011. 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 June 14, 2011. 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: November 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–31583 Filed 12–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0605] 

Small Entity Compliance Guide: 

Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 


srobinson on DSKHWCL6B1PROD with NOTICES
78716 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

1We note that the American Herbal Products 

Association submitted a petition for reconsideration 

on July 25, 2007, under 21 CFR 10.33, requesting 

reconsideration of certain provisions of the DS 

CGMP final rule. FDA is currently considering this 

petition and the SECG does not represent a 

response to such petition. 

Supplements—Small Entity Compliance 

Guide.’’ The small entity compliance 

guide (SECG) is being issued for a final 

rule and an interim final rule published 

in the Federal Register of June 25, 2007, 

and is intended to set forth in plain 

language the requirements of that final 

rule and interim final rule and to help 

small businesses understand the 

regulations. In addition, the SECG 

includes several recommendations 

made by FDA in that final rule so that 

the guidance in those recommendations 

will be readily accessible to small 

businesses. 

DATES: Submit either electronic or 

written comments on the SECG at any 

time. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments on the SECG to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. Submit written requests for 

single copies of the SECG to the 

Division of Dietary Supplement 

Programs (HFS–810), Office of 

Nutrition, Labeling, and Dietary 

Supplements, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

Bradford Williams, Center for Food 

Safety and Applied Nutrition (HFS– 

810), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1440. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 25, 

2007 (72 FR 34752), FDA issued a final 

rule establishing current good 

manufacturing practice (CGMP) 

regulations for dietary supplements (21 

CFR part 111) (the DS CGMP final rule). 

The DS CGMP final rule requires 

persons who manufacture, package, 

label, or hold a dietary supplement to 

establish and follow current good 

manufacturing practice to ensure the 

quality of the dietary supplement and to 

ensure that the dietary supplement is 

packaged and labeled as specified in the 

master manufacturing record. In that 

same issue of the Federal Register (72 

FR 34959), FDA also issued an interim 

final rule (the identity testing interim 

final rule) that sets forth a procedure for 

requesting an exemption from a 

requirement for the manufacturer to 

conduct at least one appropriate test or 

examination to verify the identity of any 

dietary ingredient that is a component 

of a dietary supplement. The final rule 

and the identity testing interim final 

rule became effective August 24, 2007. 

The compliance date of the DS CGMP 

final rule and the identity testing 

interim final rule is June 25, 2008; 

except that for businesses employing 

fewer than 500, but 20 or more full-time 

equivalent employees, the compliance 

date is June 25, 2009; and except that for 

businesses that employ fewer than 20 

full-time equivalent employees, the 

compliance date is June 25, 2010. 

FDA examined the economic 

implications of the DS CGMP final rule 

as required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612) and determined 

that the DS CGMP final rule would have 

a significant economic impact on a 

substantial number of small entities. In 

compliance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Public Law 104–121), FDA 

is making available this SECG stating in 

plain language the requirements of the 

regulations. We also examined the 

economic implications of the identity 

testing interim final rule as required by 

the Regulatory Flexibility Act and 

determined that the identity testing 

interim final rule would not have a 

significant economic impact on a 

substantial number of small entities. 

However, because the identity testing 

interim final rule revises the DS CGMP 

final rule, the SECG includes the 

provisions of the identity testing interim 

final rule. 

FDA is issuing this SECG as level 2 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c)(2)).1 The SECG restates, in 

simplified format and language, FDA’s 

requirements for Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements, including the 

requirements for a Petition to Request 

an Exemption from 100 Percent Identity 

Testing of Dietary Ingredients. In 

addition, the SECG includes several 

recommendations made by FDA in the 

DS CGMP rule so that the guidance in 

those recommendations will be readily 

accessible to small businesses. 

The SECG represents FDA’s current 

thinking on current good manufacturing 

practice in manufacturing, packaging, 

labeling, or holding operations for 

dietary supplements. 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 statutes 

and regulations. We note, however, that 

the regulations that serve as the basis for 

this guidance document establish 

requirements for all covered activities. 

For this reason, we recommend that 

affected parties consult the regulations 

at 21 CFR part 111 in addition to 

reading the SECG. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 111 have been approved 

under 0910–0606. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments on the SECG. 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 SECG at http:// 

www.fda.gov/FoodGuidances.html or 

http://www.regulations.gov. 

Dated: December 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31613 Filed 12–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

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. 


srobinson on DSKHWCL6B1PROD with NOTICES