Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 54407 

other electrical continence devices; 

protective garment for incontinence; 

surgical mesh; electrosurgical cutting 

and coagulation device and accessories; 

perineometer; gynecologic laparoscope 

and accessories; and vaginal pessary. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on clinical investigations of devices 

intended to treat urinary incontinence. 

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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Clinical 

Investigations of Devices Indicated for 

the Treatment of Urinary Incontinence,’’ 

you may either send an e-mail request 

to dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 240–276–3151 to receive 

a hard copy. Please use the document 

number 1636 to identify the guidance 

you are requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s 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 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 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 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 807, subpart 

E, have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; and 

the collections of information in parts 

50 and 56 have been approved under 

OMB control number 0910–0130. 

V. 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 2, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–21971 Filed 9–18–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0394] 

Guidance for Industry: Regulation of 

Genetically Engineered Animals 

Containing Heritable rDNA Constructs; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance 

document (GFI#187) entitled 

‘‘Regulation of Genetically Engineered 

Animals Containing Heritable rDNA 

Constructs.’’ This draft guidance is 

intended to clarify FDA’s requirements 

and recommendations for producers and 

developers of genetically engineered 

(GE) animals and their products. The 

draft guidance describes how the new 

animal drug provisions of the Federal 

Food, Drug, and Cosmetic Act (the act) 

apply with respect to GE animals, 

including FDA’s intent to exercise 

enforcement discretion regarding 

requirements for certain GE animals. 

Elsewhere in this same issue of the 

Federal Register, the Animal and Plant 

Health Inspection Service (APHIS) is 

soliciting public comment on any 

potential implications of activities such 

as the importation or interstate 

movement of GE animals on the health 

of the U.S. livestock population under 

the authority of the Animal Health 

Protection Act (AHPA). 

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 

written or electronic comments on the 

draft guidance by November 18, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document to the Communications Staff 

(HFV–12), Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Larisa Rudenko, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8247, email: larisa.rudenko@hhs.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

For the purpose of this guidance, FDA 

defines ‘‘genetically engineered (GE) 

animals’’ as those animals modified by 

recombinant DNA (rDNA) techniques. 

The term GE animal can refer to both 

animals with heritable rDNA constructs 

and animals with non-heritable rDNA 

constructs (e.g., those modifications 

intended to be used as gene therapy). 

Although much of this guidance will be 

relevant to non-heritable rDNA 

constructs, and FDA intends to regulate 

non-heritable constructs in much the 


jlentini on PROD1PC65 with NOTICES
54408 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 

1Coordinated Framework for the Regulation of 

Biotechnology: June 26, 1986; 51 FR 23302; http:// 

usbiotechreg.nbii.gov/CoordinatedFrameworkFor

RegulationOfBiotechnology1986.pdf. 

2In addition to discussing the regulatory 

responsibilities of these agencies for GE organisms 

and other products, the Coordinated Framework 

also discusses the responsibilities of agencies with 

jurisdiction over GE research (the National 

Institutes of Health, the National Science 

Foundation, the Environmental Protection Agency 

(EPA), and the U.S Department of Agriculture’s 

(USDA’s) Agricultural Research Service). 

same way as described in this guidance 

for heritable constructs, this guidance 

only pertains to GE animals containing 

heritable rDNA constructs. We may 

issue a separate guidance on the 

regulation of GE animals bearing nonheritable constructs to discuss when 

those constructs would be under FDA 

jurisdiction and the kinds of 

information that would be relevant for 

FDA’s review. 

FDA’s authority over new animal 

drugs comes from the Federal Food, 

Drug, and Cosmetic Act. The definition 

of a drug, in section 201(g) of the act (21 

U.S.C. 321(g)), includes ‘‘articles 

intended for use in the diagnosis, cure, 

mitigation, treatment, or prevention of 

disease in man or other animals;’’ and 

‘‘articles (other than food) intended to 

affect the structure or any function of 

the body of man or other animals.’’ The 

rDNA construct in a GE animal that is 

intended to affect the structure or 

function of the body of the GE animal, 

regardless of the intended use of 

products that may be produced by the 

GE animal, meets the act drug 

definition. The draft guidance describes 

how the new animal drug provisions of 

the act apply with respect to GE 

animals, including FDA’s intent to 

exercise enforcement discretion 

regarding requirements for certain GE 

animals. 

FDA is one of several Federal agencies 

that share regulatory oversight of GE 

organisms. In 1986, the Office of 

Science and Technology Policy (OSTP) 

under the Executive Office of the 

President published a policy document 

known as the Coordinated Framework 

for the Regulation of Biotechnology (the 

Coordinated Framework).1 This policy 

document describes the system for 

coordinating the activities of the Federal 

agencies responsible for regulating all 

GE organisms.2

In addition to FDA’s role in oversight 

of GE animals, APHIS is authorized, 

under the AHPA (7 U.S.C. 8301 et seq.), 

to protect the health of U.S. livestock by 

preventing the introduction and spread 

of livestock diseases and pests into and 

within the United States. Based on that 

authority, APHIS may broadly consider 

the potential effects of animals with GE 

traits on the health of the overall U.S. 

livestock population, while FDA is more 

focused on the direct effects of genetic 

engineering on individual animals 

based on its authority under the act. 

Given these complementary authorities, 

FDA and APHIS have been discussing 

their respective roles in overseeing GE 

animals for some time. In conjunction 

with FDA’s release for public comment 

of its guidance on GE animals, APHIS is 

soliciting public comment in this same 

issue of the Federal Register on any 

potential implications of activities such 

as the importation or interstate 

movement of GE animals on the health 

of the U.S. livestock population. 

II. Significance of Guidance 

This Level 1 draft guidance is being 

issued consistent with FDA’s Good 

Guidance Practices regulation (21 CFR 

10.115). This draft guidance, when 

finalized, will represent the agency’s 

current thinking on the topic. 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 

method may be used as long as it 

satisfies the requirements of applicable 

statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft 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 have been approved 

under OMB Control Nos. 0910–0032, 

0910–0045, 0910–0117, and 0910–0284. 

FDA seeks public comment on the 

agency’s determination that the 

previously approved collections of 

information referred to previously 

adequately account for the collections of 

information referenced in this guidance. 

Although the collections of information 

burden estimates previously approved 

by OMB were derived for new animal 

drug applications (NADAs) in general, 

FDA believes that such estimates are 

applicable to NADAs for GE animals. In 

particular, FDA previously determined 

that preparing the paperwork required 

for an NADA under 21 CFR 514.1 will 

take approximately 212 hours. Over the 

past 5 fiscal years, FDA has received an 

average of 19 NADAs per year. 

IV. 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: September 15, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21917 Filed 9–18–08; 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. Appendix 2), 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(cX4) 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: Oncological Sciences 

Integrated Review Group, Cancer Etiology 

Study Section. 

Date: September 29–30, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Nikko San Francisco, 222 

Mason Street, San Francisco, CA 94102. 

Contact Person: Najma Begum, PhD, 

Scientific Review Officer, Center for 


jlentini on PROD1PC65 with NOTICES