78714 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

synonymous with American Indian/ 

Alaska Native. 

L. Native American (NA)—Broadly 

describes the people considered 

indigenous to North America. 

M. Native American Affairs Advisory 

Council (NAAAC)—An internal agency 

work group to support the Assistant 

Secretary for Children and Families, the 

Commissioner of the Administration for 

Native Americans, and all ACF program 

and regional offices that provide 

services to Native Americans. 

N. Native Hawaiian—Any individual 

whose ancestors were natives of the 

area, which consists of the Hawaiian 

Islands prior to 1778 (42 U.S.C. 3057k). 

O. Inter-Tribal Organization—A 

nongovernmental body organized and 

operated to represent the interests of a 

group of individuals considered 

indigenous to North American 

countries. Organizations that represent 

the interests of individuals do not fall 

under the intergovernmental committee 

exemption to FACA found in 2 U.S.C. 

Sec 1534. Therefore, the Department is 

required to adhere to FACA if 

representatives of those organizations 

are included on advisory committees or 

workgroups. 

P. Non-Recognized Tribe—Any Tribe 

with whom the Federal Government 

does not maintain a government-togovernment relationship, and to which 

the Federal Government does not 

recognize a trust responsibility. 

Q. Policies that have Tribal 

Implications—Refers to regulations, 

legislation, and other policy statements 

or actions that have substantial direct 

effects on one or more Indian Tribes, on 

the relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

R. Public Participation—When the 

public is notified of a proposed or actual 

action, and is provided meaningful 

opportunities to participate in the 

policy development process. 

S. Reservation—Lands reserved with 

the Federal Government for tribal use 

and are usually held in trust by the 

Federal Government or within certain 

defined boundaries. 

T. Self Government—Government in 

which the people who are most directly 

affected by the decisions make 

decisions. 

U. Sovereignty—The ultimate source 

of political power from which all 

specific political powers are derived. 

V. State Recognized Tribes—Tribes 

that maintain a special relationship with 

the State government and whose lands 

and rights are usually recognized by the 

State. State recognized Tribes may or 

may not be Federally recognized. 

W. Substantial Direct Compliance 

Costs—Those costs incurred directly 

from implementation of changes 

necessary to meet the requirements of a 

Federal regulation. Because of the large 

variation in Tribes, ‘‘substantial costs’’ is 

also variable by Indian Tribe. Each 

Indian Tribe and the Secretary shall 

mutually determine the level of costs 

that represent ‘‘substantial costs’’ in the 

context of the Indian Tribe’s resource 

base. 

X. To the Extent Practicable and 

Permitted by Law—Refers to situations 

where the opportunity for consultation 

is limited because of constraints of time, 

budget, legal authority, etc. 

Y. Treaty—A legally binding and 

written agreement that affirms the 

government-to-government relationship 

between two or more nations. 

Z. Tribal Government—An American 

Indian or Alaska Native Tribe, band, 

nation, pueblo, village or community 

that the Secretary of the Interior 

acknowledges to exist as an Indian Tribe 

pursuant to the Federally recognized 

Indian Tribe List Act of 1994, (25 U.S.C. 

479a). 

AA. Tribal Officials—Elected or duly 

appointed officials of Indian Tribes or 

authorized inter-tribal organizations. 

BB. Tribal Organization—The 

recognized governing body of any 

Indian Tribe; any legally established 

organization of American Indians and 

Alaska Natives which is controlled, 

sanctioned, or chartered by such 

governing body or which is 

democratically elected by the adult 

members of the community to be served 

by such organization and which 

includes the maximum participation of 

Indian Tribe members in all phases of 

its activities (25 U.S.C. 450b). 

CC. Tribal Resolution—A formal 

expression of the opinion or will of an 

official tribal governing body which is 

adopted by vote of the tribal governing 

body. 

DD. Tribal Self-Governance—The 

governmental actions of Tribes 

exercising self-government and selfdetermination. 

14. Acronyms 

ACF Administration for Children and 

Families 

AI/AN American Indian/Alaska Native 

AI/AN/NA American Indian/Alaska Native/ 

Native American 

ANA Administration for Native Americans 

BIA Bureau of Indian Affairs 

Division Staff Division and/or Operating 

Division 

EO Executive Order 

FACA Federal Advisory Committee Act 

FR Federal Register 

HHS U.S. Department of Health and Human 

Services 

NAAAC Native American Affairs Advisory 

Council 

OPDIV Operating Divisions of HHS 

SPOC Single Point of Contact 

TFWG Tribal/Federal Workgroup 

U.S. United States 

U.S.C. United States Code 

15. Policy Review 

ACF shall review, and if necessary 

revise, its Tribal Consultation Policy no 

less than every 2 years. Should ACF 

determine that the policy requires 

revision, the Tribal/Federal Workgroup 

will be convened to develop the 

revisions. 

16. Retention of Executive Branch 

Authorities 

Nothing in this policy waives the 

Government’s deliberative process 

privilege, including when the 

Department is specifically requested by 

Members of Congress to respond to or 

report on proposed legislation. The 

development of such responses and 

related policy documents is a part of the 

deliberative process by the Executive 

Branch and should remain confidential. 

Nothing in the Policy creates a right 

of action against the Department for 

failure to comply with this Policy nor 

creates any right, substantive or 

procedural, enforceable at law by a 

party against the United States, its 

agencies, or any individual. 

17. Effective Date 

This policy is effective on the date of 

signature by the Assistant Secretary for 

Children and Families and shall apply 

to all ACF Program Offices. 

[FR Doc. 2010–31465 Filed 12–15–10; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2001–E–0027] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ANGIOMAX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ANGIOMAX and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 


srobinson on DSKHWCL6B1PROD with NOTICES
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