52862 Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Notices 

FOR FURTHER INFORMATION CONTACT: 

David Krause, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3638. 

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) 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draft guidance document entitled ‘‘Class 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.’’ FDA 

invited interested persons to comment 

on the draft guidance document by 

January 29, 2007. In the Federal 

Register of May 8, 2007 (72 FR 26134), 

FDA published a notice reopening the 

comment period for 30 days. 

On July 2, 2007, FDA received a 

petition under 21 CFR 10.30 and 10.35 

requesting that the agency refrain from 

issuing a final regulation for the 

proposed reclassification and the draft 

special controls guidance for the 

absorbable hemostatic device until an 

updated and complete administrative 

record is made available to the public. 

The petitioner also requested that FDA 

reopen the rulemaking for the proposed 

reclassification to allow submission of 

comments based on the administrative 

record. 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of the draft guidance may do so by using 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 

Specials 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 applications and 

manufacturers’’ addresses), small 

manufacturer’’ 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. 

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. 

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 submissions will be accepted 

by FDA through FDMS only. 

Dated: September 4, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21197 Filed 9–10–08; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0475] 

Request for Notification From Industry 

Organizations Interested in 

Participating in Selection Process for 

Nonvoting Industry Representatives on 

Public Advisory Panels or Committees 

and Request for Nonvoting Industry 

Representatives on Public Advisory 

Panels or Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organization interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on the Devices Good 

Manufacturing Practice Advisory 

Committee (DGMPAC) and certain 

device panels of the Medical Devices 

Advisory Committee in the Center for 

Devices and Radiological Health notify 

FDA in writing. A nominee may either 

be self nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current vacancies 

effective with this notice. 

DATES: Any industry organizations 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by October 14, 2008, for the 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA by October 14, 2008. 

ADDRESSES: All letters of interest and 

nominations should be sent to Kathleen 

L. Walker (see FOR FURTHER INFORMATION

CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Kathleen L. Walker, Center for Devices 

and Radiological Health (HFZ–17), Food 

and Drug Administration, 7520 Standish 

Pl. (MPN1), Rockville, MD 20855, 240–

276–8938, e-mail: 

kathleen.walker@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

agency intends to add nonvoting 

industry representatives to the following 

advisory committees: 

I. CDRH—Various Committees and 

Panels 

A. Devices Good Manufacturing Practice 

Advisory Committee (DGMPAC) 

Section 520 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360(j)), as amended, provides that the 

DGMPAC shall be composed of two 

representatives of interests of the device 

manufacturing industry. 

B. Medical Devices Advisory Committee 

Section 520(f)(3) of the act, as 

amended by the Medical Device 

Amendments of 1976, provides that 

each medical device panel include one 

nonvoting member to represent the 

interests of the medical device 

manufacturing industry. 


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Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Notices 52863 

II. CDRH—Committee and Panels 

Functions 

FDA is requesting nominations for 

nonvoting members representing 

industry interests for the following 

vacancies listed in table 1 of this 

document. 

TABLE 1. 

Committee Name or Panel Approximate Date Needed 

DGMPAC—The functions of the committee are to review proposed regulations 

issuance regarding good manufacturing practices governing the methods used 

in, and the facilities and controls used for manufacture, packaging, storage, installation, and servicing of devices, and make recommendations regarding the 

feasibility and reasonableness of those proposed regulations. The committee 

also reviews and makes recommendations on proposed guidelines developed to 

assist the medical device industry in meeting the good manufacturing practice 

requirements, and provides advice with regard to any petition submitted by a 

manufacturer for an exemption or variance from good manufacturing practice 

regulations. 

Immediately 

Certain Panels of the Medical Devices Advisory Committee—The medical device 

panels perform the following functions: (1) Review and evaluate data on the 

safety and effectiveness of marketed and investigational devices and make recommendations for their regulation, (2) advise the Commissioner of Food and 

Drugs (the Commissioner) regarding recommended classification or reclassification of these devices into one of three regulatory categories, (3) advise on any 

possible risks to health associated with the use of devices, (4) advise on formulation of product development protocols, (5) review premarket approval applications for medical devices, (6) review guidelines and guidance documents, (7) 

recommend exemption to certain devices from the application of portions of the 

act, (8) advise on the necessity to ban a device, (9) respond to requests from 

the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices, and (10) make recommendations on the quality in the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. 

Circulatory System Devices Panel July 1, 2009 

Ear, Nose and Throat Devices Panel November 1, 2008 

Neurological Devices Panel December 1, 2008 

Obstetrics and Gynecology Devices Panel February 1, 2009 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) within 30 days of 

publication of this notice. Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations, 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for a particular committee or 

device panel. The interested 

organizations are not bound by the list 

of nominees in selecting a candidate. 

However, if no individual is selected 

within the 60 days, the Commissioner 

will select the nonvoting member to 

represent industry interests. 

IV. Qualifications 

A. DGMPAC 

Persons nominated for membership as 

an industry representative on the 

DGMPAC should possess appropriate 

qualifications to understand and 

contribute to the committee’s work. The 

particular needs for this committee are 

listed in section II of this document. 

B. Medical Devices Advisory Committee 

Persons nominated for the device 

panels should be full-time employees of 

firms that manufacture products that 

would come before the panel, or 

consulting firms that represent 

manufacturers, or have similar 

appropriate ties to industry. 

V. Application Procedure 

Individuals may self nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. A current 

curriculum vitae and the name of the 

committee or panel of interest should be 

sent to the FDA contact person (see FOR

FURTHER INFORMATION CONTACT) within 

30 days. FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the committee 

or panel. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages nominations 

for appropriately qualified candidates 

from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 3, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–21016 Filed 9–10–08; 8:45 am] 

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