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, 52862-52863 [E8-21016]

Download as PDF 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: rmajette on PRODPC74 with NOTICES 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 In the same issue of the Federal Register (71 FR 63774), FDA published a notice of availability of a draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Absorbable Hemostatic Device.’’ FDA invited interested persons to comment on the draft guidance document by January 29, 2007.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 Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive the draft guidance document entitled ‘‘Class II Specials Controls Document: Absorbable Hemostatic Device,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive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 VerDate Aug<31>2005 14:21 Sep 10, 2008 Jkt 214001 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available at https://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] BILLING CODE 4160–01–S 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. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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. 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. DATES: All letters of interest and nominations should be sent to Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT). ADDRESSES: 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. The agency intends to add nonvoting industry representatives to the following advisory committees: SUPPLEMENTARY INFORMATION: 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. E:\FR\FM\11SEN1.SGM 11SEN1 Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Notices 52863 industry interests for the following vacancies listed in table 1 of this document. II. CDRH—Committee and Panels Functions FDA is requesting nominations for nonvoting members representing 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. 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 Ear, Nose and Throat Devices Panel Neurological Devices Panel Obstetrics and Gynecology Devices Panel rmajette on PRODPC74 with NOTICES III. Selection Procedure July 1, 2009 November 1, 2008 December 1, 2008 February 1, 2009 IV. Qualifications 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. Immediately A. DGMPAC VerDate Aug<31>2005 14:21 Sep 10, 2008 Jkt 214001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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] BILLING CODE 4160–01–S E:\FR\FM\11SEN1.SGM 11SEN1

Agencies

[Federal Register Volume 73, Number 177 (Thursday, September 11, 2008)]
[Notices]
[Pages 52862-52863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21016]


-----------------------------------------------------------------------

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.

[[Page 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    Immediately
 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.
------------------------------------------------------------------------
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     February 1, 2009
     Panel
------------------------------------------------------------------------

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]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.