26134 Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Completed survey 44,500 1 44,500 .75 33,375 

Total domestic 61,500 61,500 34,514 

Foreign Facilities 

Screening questions only 14,000 1 14,000 .067 938 

Completed survey 26,000 1 26,000 .75 19,500 

Total foreign 40,000 1 40,000 20,438 

Grand total 101,500 54,952 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

These estimates of the number of 

respondents and the burden hours per 

response are based on FDA’s registration 

database and FDA and the contractor’s 

experience with previous surveys. The 

respondents are divided into two 

groups: Domestic and foreign. We 

estimate the number of domestic 

facilities at 126,000 based on 

information in the registration database. 

However, we do not expect that all of 

these firms will participate in the 

survey. We anticipate that 

approximately 61,500 facilities will 

participate, which takes into account 

typical response rates to these types of 

surveys and inaccurate contact 

information that facilities have entered 

into the registration database (see http:// 

www.cfsan.fda.gov/~furls/ 

ffregacc.html). Similarly, among the 

81,000 foreign facilities in the 

registration database, we expect that 

40,000 foreign facilities will respond. 

We estimate that it will take a 

respondent 4 minutes (.067 hours) to 

complete the screening questions and 45 

minutes (0.75 hours) to complete the 

entire survey. Prior to the 

administration of the survey, the agency 

plans to conduct a pretest of the final 

survey to identify and resolve potential 

problems. The pretest will be conducted 

with nine participants. 

Dated: May 2, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8783 Filed 5–7–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0363] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Absorbable Hemostatic Device; 

Availability; Reopening of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

June 7, 2007, the comment period for a 

draft guidance entitled ‘‘Class II Special 

Controls Guidance Document: 

Absorbable Hemostatic Device.’’ FDA 

published a notice of availability of the 

draft guidance in the Federal Register of 

October 31, 2006 (71 FR 63774). The 

draft guidance describes a means by 

which the absorbable hemostatic device 

may comply with the requirement of 

special controls for class II devices, if 

the device is reclassified. Elsewhere in 

this issue of the Federal Register, FDA 

is reopening the comment period on a 

proposed rule to reclassify the 

absorbable hemostatic device from class 

III (premarket approval) into class II 

(special controls) 

DATES: Submit written or electronic 

comments on the draft guidance by June 

7, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: 

Absorbable Hemostatic Device’’ 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 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: 

David Krause, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3090, ext. 141. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 31, 

2006 (71 FR 63728), FDA published a 

proposed rule to reclassify the 

absorbable hemostatic device intended 

to produce hemostasis from class III 

(premarket approval) into class II 

(special controls). In the same issue of 

the Federal Register (71 FR 63774), FDA 

published a notice of availability of a 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Absorbable Hemostatic Device.’’ The 

draft guidance describes a means by 

which the absorbable hemostatic device 

may comply with the requirement of 

special controls if they were 

reclassified. FDA invited interested 

persons to comment on the proposed 


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Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices 26135 

rule and on the draft guidance 

document by January 29, 2007. 

Two companies requested FDA to 

extend the comment period on the 

proposed rule by 90 days because the 

proposal presented complex medical 

and scientific issues that required the 

company to assemble a team of many 

different specialties in order to prepare 

their comments. Elsewhere in this issue 

of the Federal Register, FDA is 

reopening the comment period on the 

proposed rule for 30 days. Because the 

issues presented by the guidance 

document are intertwined with those 

presented by the proposed rule, FDA is 

reopening the comment period on the 

guidance document for the same period. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive the draft 

guidance document entitled ‘‘Class II 

Special Controls Document: Absorbable 

Hemostatic Device,’’ 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 1558 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 submissions, 

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 are also available on the 

Division of Dockets Management 

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

ohrms/dockets. 

III. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance 

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. 

Dated: April 25, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8780 Filed 5–7–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0027] 

Voluntary Self-Inspection of Medicated 

Feed Manufacturing Facilities; Draft 

Compliance Policy Guide; Availability; 

Reopening of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening to 

June 8, 2007, the comment period for 

the notice of availability that appeared 

in the Federal Register of February 12, 

2007 (72 FR 6572). In the notice, FDA 

requested comments on the draft 

compliance policy guide on voluntary 

self-inspection of medicated feed 

manufacturing facilities. 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 June 8, 2007. 

ADDRESSES: Submit written comments 

on the draft compliance policy guide 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: Paul 

Bachman, Center for Veterinary 

Medicine (HFV–230), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9225, email: Paul.Bachman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

12, 2007 (72 FR 6572), FDA published 

a notice of availability with a 75-day 

comment period to request comments 

on a draft compliance policy guide 

(CPG) on voluntary self inspection of 

medicated feed manufacturing facilities. 

The purpose of this CPG is intended to 

provide guidance to FDA field offices on 

considering, among other factors, the 

conduct of self-inspections when 

prioritizing inspections of medicated 

feed manufacturing facilities for 

compliance with Current Good 

Manufacturing Practices for Medicated 

Feeds regulations. 

The agency has received a request for 

an extension of the comment period for 

the draft compliance policy guide. This 

request conveyed concern that the 

current 75-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the compliance policy guide. 

FDA has considered the request and 

is reopening the comment period for the 

draft compliance policy guide until June 

8, 2007. The agency believes this 

reopening 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: May 1, 2007. 

David Horowitz, 

Assistant Commissioner for Regulatory 

Affairs. 

[FR Doc. E7–8781 Filed 5–7–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review—Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 


cprice-sewell on PROD1PC66 with NOTICES