54406 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices 

listing information under the 

regulations, and exhibit vendor SPL 

authoring tools that may be used in the 

creation and manipulation of SPL 

content of labeling. 

Date and Time: The public workshop 

will be held on November 17, 2008, 

from 8:30 a.m. to 4 p.m. 

Location: The public workshop will 

be held at the Universities at Shady 

Grove, Multipurpose Room, Building II, 

9630 Gudelsky Dr., Rockville, MD 

20850. 

Contact Person: Donna Lipscomb, 

Center for Biologics Evaluation and 

Research (HFM–43), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–2000, FAX: 301–827–3079; email: spl@fda.hhs.gov (Subject line: 

CBER SPL Public Workshop). 

Registration: Mail, FAX, or e-mail 

your registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

contact person by October 30, 2008. 

There is no registration fee for the 

public workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space-available basis beginning at 8 a.m. 

Vendor Registration: Vendors wishing 

to exhibit their SPL authoring tools at 

this public workshop must register and 

submit their registration information 

(including name, title, firm name, 

address, telephone and fax numbers) to 

the contact person by October 30, 2008, 

via e-mail to spl@fda.hhs.gov. 

If you need special accommodations 

due to a disability, please contact Donna 

Lipscomb (see Contact Person) at least 

7 days in advance. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public workshop to 

provide the biologics industry with 

guidance on submitting to FDA content 

of labeling in SPL format and to present 

an overview of FDA’s voluntary pilot 

program for electronic submission of 

drug establishment registration and drug 

listing information under the 

regulations in part 207 (21 CFR part 

207). 

FDA’s Center for Biologics Evaluation 

and Research (CBER) has stated in a 

memorandum, posted on July 11, 2008, 

to Docket No. FDA–1992–S–0039 

(formerly 1992S–0251), that beginning 

October 15, 2008, SPL in XML 

(extensible markup language) is the 

acceptable presentation in electronic 

format for the submission of content of 

labeling that CBER can process, review, 

and archive. This applies to the content 

of labeling with original submissions, 

supplements, and annual reports. 

Individuals may electronically access 

CBER’s notification on the submission 

of SPL content of labeling at http:// 

www.fda.gov/oc/datacouncil/spl.html. 

In the Federal Register of July 11, 

2008 (73 FR 39964), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Drug Establishment Registration and 

Drug Listing.’’ This draft guidance 

established a pilot program for industry 

to voluntarily submit drug 

establishment registration and drug 

listing information in SPL format. The 

draft guidance only applies to drug 

establishments that currently register 

their establishments and list their 

products under the regulations in part 

207 and explains how to transition from 

submitting the required information on 

paper to submitting the required 

information using the SPL standard. The 

draft guidance also describes how to 

voluntarily submit additional useful, 

but not required, information that 

currently is often included by industry 

in their registration and listing paper 

submissions. FDA plans to complete the 

voluntary pilot program and begin 

receiving drug establishment and drug 

listing information only electronically 

and only in SPL format (including 

labeling) beginning June 1, 2009, unless 

a waiver is granted. 

This public workshop will feature 

presentations by FDA experts on SPL 

content of labeling and electronic drug 

establishment registration and drug 

listing. In addition, registrants will have 

access to a vendor exhibition of SPL 

authoring tools. 

Dated: September 15, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21968 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–0457] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Clinical 

Investigations of Devices Indicated for 

the Treatment of Urinary Incontinence; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Clinical Investigations of 

Devices Indicated for the Treatment of 

Urinary Incontinence.’’ This draft 

guidance document describes FDA’s 

proposed recommendations for clinical 

investigations of medical devices 

indicated for the treatment of urinary 

incontinence. This draft guidance is not 

final nor is it in effect at this time. 

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 December 18, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Clinical 

Investigations of Devices Indicated for 

the Treatment of Urinary Incontinence’’ 

to the Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850.Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Baxley, Center for Devices and 

Radiological Health (HFZ–470), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4130. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Urinary incontinence is defined as the 

involuntary loss of urine. This draft 

guidance is intended to assist device 

manufacturers who plan to conduct 

clinical investigations of devices 

intended to treat urinary incontinence 

in support of premarket approval (PMA) 

applications or premarket notification 

(510(k)) submissions. The draft 

guidance describes FDA’s proposed 

recommendations for human clinical 

trials that involve the use of any type of 

urinary incontinence device, including, 

but not limited to, urological clamp for 

males; nonimplanted, peripheral and 


jlentini on PROD1PC65 with NOTICES
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