Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices 41083 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturers’ assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the CBER Internet site at http:// 

www.fda.gov/cber/guidelines.htm or on 

the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

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of information in the draft guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing premarket 

notifications (21 CFR part 807, subpart 

E, OMB control number 0910–0120) 

premarket approval applications (21 

CFR part 814, OMB control number 

0910–0231), investigational device 

exemptions (21 CFR part 812, OMB 

control number 0910–0078), quality 

system regulation (21 CFR part 820, 

OMB control number 0910–0073), and 

medical device reporting (21 CFR part 

803, OMB control number 0910–0437). 

The labeling provisions addressed in 

this guidance have been approved by 

OMB under OMB control number 0910–

0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document on 

or before August 27, 2007. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Submit two paper copies of any mailed 

comments, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Comments received may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: July 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–3660 Filed 7–23–07; 12:02 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0333] 

Guidance; Emergency Use 

Authorization of Medical Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Emergency Use Authorization of 

Medical Products.’’ The guidance 

explains FDA’s policies for authorizing 

the use of an unapproved medical 

product or an unapproved use of an 

approved medical product during a 

declared emergency. This guidance 

finalizes the draft guidance published in 

the Federal Register of July 5, 2005 (70 

FR 38689). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Office of Counterterrorism Policy and 

Planning (HF–29), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

14C–26, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request, or 

fax your request to 301–827–5671. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Charlotte Christin, Office of 

Counterterrorism Policy and Planning 

(HF–29), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4067. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry, government 

agencies, and FDA staff entitled 

‘‘Emergency Use Authorization of 

Medical Products.’’ This guidance 

describes the agency’s general 

recommendations and procedures for 

issuance of emergency use 

authorizations (EUA) under section 564 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360bbb–3), 

which was amended by the Project 

BioShield Act of 2004 (Public Law 108–

276). 

Section 564 of the act provides for 

authorization of ‘‘emergency use’’ of a 

medical product, after a declaration of 

emergency justifying an authorization is 

issued by the Secretary of Health and 

Human Services (the Secretary) based 

on one of the following grounds: A 

determination by the Secretary of 

Homeland Security that there is an 

actual or potential ‘‘domestic 

emergency;’’ a determination by the 

Secretary of Defense that there is an 

actual or potential ‘‘military 

emergency;’’ or a determination by the 

Secretary that there is a public health 

emergency under section 319 of the 

Public Health Service Act that affects or 

has the significant potential to affect 

national security. The Commissioner of 

Food and Drugs may issue an EUA for 

an unapproved drug, device, or biologic, 

or an unapproved use of an approved 

drug, device, or biologic, during a 

declared emergency if the statutory 

criteria set forth in section 564 of the act 

are met. 

On July 5, 2005, FDA published for 

comment in the Federal Register a draft 

of this guidance. Comments received 

from industry, associations, health care 

professionals, consumers, and staff of 

other Federal agencies have been taken 

into consideration in finalizing this 

guidance. Changes are based on a 

thorough review of all comments 

received. As revised, the guidance 

includes a more detailed discussion of 

the scope of preemption (where 

applicable) and also provides points of 

contact for further information on 

several Federal liability protection and 

compensation programs. 

This guidance document is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). It represents the agency’s 

current thinking on emergency use 

authorizations of medical products. 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. 


rwilkins on PROD1PC63 with NOTICES
41084 Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

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. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information. 

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). These 

collections of information have been 

approved under OMB control numbers 

0910–0308, 0910–0230, 0910–0471, 

0910–0014, 0910–0078, and 0910–0595. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: July 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–3661 Filed 7–23–07; 12:28 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

Stone Lakes National Wildlife Refuge, 

Sacramento County, CA 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability: final 

comprehensive conservation plan and 

finding of no significant impact. 

SUMMARY: The U.S. Fish and Wildlife 

Service (Service) announces that the 

Stone Lakes National Wildlife Refuge 

(Refuge) Final Comprehensive 

Conservation Plan (CCP), and Finding of 

No Significant Impact (FONSI) are 

available for distribution. The CCP 

prepared pursuant to the National 

Wildlife Refuge System Improvement 

Act of 1997, and in accordance with the 

National Environmental Policy Act of 

1969, describes how the Service will 

manage the Refuge for the next 15 years. 

DATES: The CCP and FONSI are 

available now. Implementation of the 

CCP may begin immediately. 

ADDRESSES: Copies of the CCP may be 

obtained by writing to the U.S. Fish and 

Wildlife Service, Attn: David 

Bergendorf, CNO Refuge Planning 

Office, 2800 Cottage Way, W–1832, 

Sacramento, CA 95825. Copies of the 

CCP may be viewed at this address or 

at Stone Lakes National Wildlife Refuge, 

1624 Hood-Franklin Road, Elk Grove, 

CA 95757. The CCP is also available for 

viewing and downloading online at: 

http://www.fws.gov/stonelakes/ccp.htm. 

Printed copies of the CCP and FONSI 

are also available at the following 

libraries: Sacramento Central Library, 

828 I Street, Sacramento, CA 95814; 

Arden-Dimick Library, 891 Watt 

Avenue, Sacramento, CA 95864; Belle 

Cooledge Library, 5600 South Land Park 

Drive, Sacramento, CA 95822; Elk Grove 

Library, 8962 Elk Grove Blvd., Elk 

Grove, CA 95624; Clarksburg Yolo 

County Library, 52915 Netherlands 

Road, Clarksburg, CA 95612; Colonial 

Heights Library, 4799 Stockton Blvd., 

Sacramento, CA 95820; Courtland 

Library Neighborhood Library, 170 

Primasing Avenue, Courtland, CA 

95615; and the Galt Branch Library 

(Marian O. Lawrence Library), 1000 

Caroline Avenue, Galt, CA 95632. 

FOR FURTHER INFORMATION CONTACT: 

Beatrix Treiterer, acting Project Leader, 

Stone Lakes National Wildlife Refuge, 

1624 Hood-Franklin Road, Elk Grove, 

CA 95757 or David Bergendorf, Refuge 

Planner, 2800 Cottage Way, W–1832, 

Sacramento, CA 95825, phone (916) 

414–6503. 

SUPPLEMENTARY INFORMATION: 

Background 

The Refuge was established in 1994 

primarily to protect and manage 

wintering habitat for migratory birds 

and to protect endangered and 

threatened species. The Refuge is 

located in the Beach-Stone Lakes Basin 

within the Sacramento Valley in 

southwestern Sacramento County; it lies 

south of the city of Sacramento, 

straddling Interstate 5 from the town of 

Freeport south to Lost Slough. 

The Draft CCP and Environmental 

Assessment (EA) was available for a 30- 

day public review and comment period, 

which was announced via several 

methods including press releases; 

updates to constituents; and in the 

Federal Register (71 FR 55801, 

September 25, 2006). Due to requests 

from constituents, the review and 

comment period was extended for an 

additional 30 days. The Draft CCP/EA 

identified and evaluated three 

alternatives for managing the Refuge for 

the next 15 years. Alternative A was the 

no-action alternative, which described 

current Refuge management activities. 

Alternative B emphasized continued 

focus on providing wintering habitat for 

migratory birds and management for the 

benefit of special status species as well 

as expanding overall visitor services. 

Alternative C focused on providing 

wintering habitat for migratory birds 

and management for the benefit of 

endangered species, while placing 

greater emphasis on management and 

restoration of historic habitat conditions 

and expanding overall visitor services. 

The Service received 25 letters, faxes 

and e-mails, and one phone call on the 

Draft CCP and EA during the review 

period. Many comments were also 

received during two public comment 

meetings, which were held on October 

4 and 5, 2006. The comments received 

were incorporated into the CCP, when 

possible, and are responded to in an 

appendix to the CCP. In the FONSI, 

Alternative B was selected for 

implementation and is the basis for the 

CCP. The FONSI documents the 

decision of the Service and is based on 

the information and analysis contained 

in the EA. 

Under the selected alternative, the 

Refuge will continue its focus of 

providing wintering habitat for 

migratory birds and management to 

benefit endangered species. 

Management programs for migratory 

birds and other Central Valley wildlife 

will be expanded and improved and 

public use opportunities will also be 

expanded. The number of Refuge units 

open to the public will increase from 

one to five. In addition, environmental 

education, interpretation, wildlife 

observation, wildlife photography, 

hunting, and fishing programs will be 

expanded. 

The selected alternative best achieves 

the Refuge’s purposes, vision, and goals; 

contributes to the Refuge System 

mission; addresses the significant issues 

and relevant mandates; and is consistent 

with principles of sound fish and 

wildlife management. 

Dated: July 20, 2007. 

Ken McDermond, 

Acting Manager, California/Nevada 

Operations, Sacramento, California. 

[FR Doc. E7–14425 Filed 7–25–07; 8:45 am] 

BILLING CODE 4310–55–P 


rwilkins on PROD1PC63 with NOTICES