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management plan, and draft guidance.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management plan, and draft guidance 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
Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices 15889 

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 Division of Dockets Management 

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

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This 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 807 subpart E have been 

approved under OMB Control No. 0910–

0120; and the collections of information 

in 21 CFR part 801 and 21 CFR 809.10 

have been approved under OMB Control 

No. 0910–0485. 

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. The guidance 

and received comments may be seen in 

the Division of Dockets Management 

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

through Friday. 

Dated: March 23, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–6168 Filed 4–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

To request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer on (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Federally Qualified 

Health Centers (FQHC) Application 

Forms: (OMB No. 0915–0285 Revision) 

HRSA’s Bureau of Primary Health 

Care (BPHC) FQHCs are a major 

component of America’s health care 

safety net, the Nation’s ‘‘system’’ of 

providing health care to low-income 

and other vulnerable populations. 

Health centers care for people regardless 

of their ability to pay and whether or 

not they have health insurance. They 

provide primary and preventive health 

care, as well as services such as 

transportation and translation. Many 

health centers also offer dental, mental 

health, and substance abuse care. 

FQHCs are administered by HRSA’s 

BPHC. 

HRSA uses the following application 

forms to administer and manage FQHCs. 

These application forms are used by 

new and existing FQHCs to apply for 

grant and non-grant opportunities, renew their grant or non-grant 

opportunities, or change their scope of 

project. 

Estimated of annualized reporting 

burden are as follows: 

Type of application form 

Number of 

respondents 

Responses 

per respondent 

Total number of responses 

Hours per 

response 

Total burden hours 

General Information Worksheet ......................................................................... 1,021 1 1,021 3.0 3,063 

P12 Planning General Information Worksheet .................................................. 300 1 300 12.0 3,600 

BPHC Funding Request Summary .................................................................... 1,021 1 1,021 0.5 510 

Institutional File Assurances .............................................................................. 1,021 1 1,021 0.5 510 

Proposed Staff Profile ........................................................................................ 1,021 1 1,021 6.0 6,126 

Income Analysis Form ....................................................................................... 1,021 1 1,021 15.0 15,315 

Community Characteristics ................................................................................ 1,021 1 1,021 12.0 12,252 

Services Provided .............................................................................................. 1,021 1 1,021 0.5 510 

Sites Listing ........................................................................................................ 1,021 1 1,021 1.0 1,021 

Other Site Activities ........................................................................................... 700 1 700 0.5 350 

Board Member Characteristics .......................................................................... 1,021 1 1,021 1.0 1,021 

Request for Waiver of Governance Requirements ........................................... 150 1 150 1.0 150 

Compliance Matrix ............................................................................................. 1,021 1 1,021 0.5 510 

Health Center Affiliation Certification ................................................................. 250 1 250 0.5 125 

Need for Assistance ........................................................................................... 900 1 900 6.0 5,400 

Emergency Preparedness Form ........................................................................ 1,021 1 1,021 1.0 1,021 

FTCA Form ........................................................................................................ 800 1 800 1.0 800 

Points of Contact ............................................................................................... 800 1 800 0.5 400 

Total ............................................................................................................ 15,131 .................. 15,131 .................. 52,684 

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 14–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice. 


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