Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices 15887 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Oncologic Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 9, 2007, from 8 a.m. to 4 

p.m. and May 10, 2007, from 8 a.m. to 

5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, 8727 Colesville Rd., 

Silver Spring, MD, 301–589–5200. 

Contact Person: Johanna Clifford, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5630 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093) Rockville, MD 20857, 301–827–

6761, FAX: 301–827–6776, e-mail: 

johanna.clifford@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On May 9, 2007, the 

committee will do the following: (1) 

Discuss new drug application (NDA) 

022–092, proposed trade name 

JUNOVAN (mifamurtide), IDM Pharma, 

Inc., proposed indication for the 

treatment of newly diagnosed resectable 

high grade osteosarcoma following 

surgical resection in combination with 

multiple agent chemotherapy; and (2) 

discuss NDA 022–062, proposed trade 

name ORBEC (beclomethasone 

dipropionate), DOR BioPharma, Inc., 

proposed indication for the treatment of 

graft versus host disease (GvHD) 

involving the gastrointestinal tract in 

conjunction with an induction course of 

high-dose prednisone or prednisolone. 

On May 10, 2007, the committee will 

discuss updated information on risks of 

erythropoeisis-stimulating agents 

(ARANESP, Amgen, Inc., EPOGEN, 

Amgen, Inc., and PROCRIT, Amgen, 

Inc.) for use in the treatment of anemia 

due to cancer chemotherapy. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 25, 2007. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. 

on May 9 and from 10:45 a.m. to 11:45 

a.m. on May 10. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before April 19, 2007. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 18, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Johanna 

Clifford at least 7 days in advance of the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 28, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–6171 Filed 4–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003N–0573] 

Draft Animal Cloning Risk 

Assessment; Proposed Risk 

Management Plan; Draft Guidance for 

Industry; Availability; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

May 3, 2007, the comment period for 

the notice of availability that appeared 

in the Federal Register of January 3, 

2007 (72 FR 136). In the notice, FDA 

requested comments on the draft risk 

assessment, the proposed risk 

management plan, and the draft 

guidance for industry on animal 

cloning. The agency is taking this action 

in response to requests for an extension 

to allow interested persons additional 

time to submit comments. 

DATES: Submit written and electronic 

comments by May 3, 2007. 

ADDRESSES: Submit written comments 

on the draft risk assessment, proposed 

risk management plan, or draft guidance 

for industry 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 electronic access to the documents. 

FOR FURTHER INFORMATION CONTACT: 

Larisa Rudenko, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–453–6842, email: clones@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 3, 

2007 (72 FR 136), FDA published a 

notice of availability with a 90-day 

comment period to request comments 

on a draft risk assessment to evaluate 

the health effects to animals involved in 

the process of cloning and to evaluate 

the food consumption risks that may 

result from edible products derived 

from animal clones or their progeny. 

FDA also announced the availability for 

public comment of a proposed risk 

management plan for animal clones and 

their progeny and a draft guidance for 

industry describing FDA’s 


ycherry on PROD1PC64 with NOTICES
15888 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices 

recommendations regarding the use of 

edible products from animal clones and 

their progeny in human food or in 

animal feed. 

The agency has received requests for 

an extension of the comment period for 

the draft risk assessment, proposed risk 

management plan, and draft guidance. 

These requests conveyed concern that 

the current 90-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the cloning documents. 

FDA has considered the requests and 

is extending the comment period for the 

draft risk assessment, proposed risk 

management plan, and draft guidance 

until May 3, 2007. The agency believes 

this extension allows adequate time for 

interested persons to submit comments. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on these documents. 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. 

Dated: March 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6170 Filed 4–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Docket No. 2005D–0468 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological 

Assays.’’ This guidance document 

describes a means by which herpes 

simplex virus type 1 and 2 (HSV 1 and 

2) serological assays may comply with 

the requirement of special controls for 

class II devices. Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a final rule reclassifying 

these devices from class III (premarket 

approval) into class II (special controls). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological Assays’’

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 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Sally Hojvat, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–0496. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 9, 

2006 (71 FR 1399), FDA published a 

proposed rule to reclassify herpes 

simplex virus types 1 and 2 serological 

assays from class III (premarket 

approval) into class II (special controls). 

In addition, FDA issued a draft class II 

special controls guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological Assays’’

to support the proposed reclassification. 

Herpes simplex virus types 1 and 2 

serological assays are in vitro diagnostic 

devices that test for specific antibodies. 

In conjunction with other clinical 

laboratory findings, the detection of 

these HSV type 1 and/or 2 -specific 

antibodies aids in the clinical laboratory 

diagnosis of an acute or past infection 

by HSV type 1 and/or 2. FDA did not 

receive any comments on the proposed 

reclassification. FDA is now identifying 

the guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays’’ as the guidance 

document that will serve as the special 

control for these devices. 

The guidance document provides a 

means by which herpes simplex virus 

types 1 and 2 serological assays may 

comply with the requirement of special 

controls for class II devices. Following 

the effective date of the final 

reclassification rule, any firm 

submitting a premarket notification 

(510(k)) for herpes simplex virus type 1 

and 2 serological assays will need to 

address the issues covered in the special 

controls guidance document. However, 

the firm need only show that its device 

meets the recommendations of the 

guidance document or in some other 

way provides equivalent assurances of 

safety and effectiveness. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on herpes simplex 

virus types 1 and 2 serological assays. 

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 guidance may do so by using the 

Internet. To receive ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays’’ 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 1305 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, 


ycherry on PROD1PC64 with NOTICES