Request for Nominations on Device Good Manufacturing Practice Advisory Committee, 27265-27266 [2017-12326]

Download as PDF Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 379,493, or 18,975 firms. Thus, we estimate that approximately 18,975 facilities will spend 4.790 hours learning about the recordkeeping and records access requirements, for a total of 90,890 hours annually. We estimate that approximately the same number of firms (18,975) will exit the affected businesses in any given year, resulting in no growth in the number of total firms reported on line 1 of table 1. Therefore, the total annual recordkeeping burden is estimated to be 5,110,890 hours. Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–12327 Filed 6–13–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–2463] Request for Nominations on Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for the upcoming vacancy 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 July 14, 2017 (see sections I and III of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by July 14, 2017. ADDRESSES: All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:36 Jun 13, 2017 nominations should be sent to Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives should be submitted electronically by accessing FDA’s Advisory Committee Membership Nomination Portal at https://www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm. Jkt 241001 Margaret Ames, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301–796–5960, FAX: 301–847–8505, email: margaret.ames@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360j), as amended, provides that DGMPAC shall be composed of two representatives of interests of the device manufacturing industry. The Agency is requesting nominations for a nonvoting industry representative on DGMPAC. FDA is publishing a separate document announcing the request for notification for voting members on DGMPAC. I. Function of DGMPAC DGMPAC reviews proposed regulations issuance regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packaging, storage, installation, and servicing of devices, and makes 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. II. Qualifications Persons nominated for DGMPAC should possess appropriate qualifications to understand and contribute to the committee’s work as described in the committee’s function. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 27265 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 FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). 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 the committee. 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 of Food and Drugs will select the nonvoting member to represent industry interests. IV. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the device manufacturing industry. 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. E:\FR\FM\14JNN1.SGM 14JNN1 27266 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993, 301–796– 7047, email: Sara.Anderson@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the National Mammography Quality Assurance Advisory Committee. [FR Doc. 2017–12326 Filed 6–13–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before August 14, 2017, will be given first consideration for membership on the National Mammography Quality Assurance Advisory Committee. Nominations received after August 14, 2017, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:36 Jun 13, 2017 Jkt 241001 I. General Description of the Committee Duties The National Mammography Quality Assurance Advisory Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. II. Criteria for Voting Members The committee consists of a core of 15 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete resume or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available. Nominations must specify the PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. 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: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–12312 Filed 6–13–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2015–E–0635; FDA– 2015–E–0634; FDA–2015–E–0629] Determination of Regulatory Review Period for Purposes of Patent Extension; NEUROPACE RNS SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for NEUROPACE RNS SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. SUMMARY: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 14, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 11, 2017. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be DATES: E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27265-27266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2463]


Request for Nominations on Device Good Manufacturing Practice 
Advisory Committee

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 a 
nonvoting industry representative to serve on the Device Good 
Manufacturing Practice Advisory Committee (DGMPAC) in the Center for 
Devices and Radiological Health notify FDA in writing. FDA is also 
requesting nominations for a nonvoting industry representative to serve 
on DGMPAC. A nominee may either be self-nominated or nominated by an 
organization to serve as a nonvoting industry representative. 
Nominations will be accepted for the upcoming vacancy 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 July 14, 
2017 (see sections I and III of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by July 14, 2017.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nominations should be sent to Margaret Ames 
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting 
industry representatives should be submitted electronically by 
accessing FDA's Advisory Committee Membership Nomination Portal at 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or 
by mail to Advisory Committee Oversight and Management Staff, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, 
Silver Spring, MD 20993-0002. Information about becoming a member of an 
FDA advisory committee can also be obtained by visiting FDA's Web site 
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Office of Management, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver 
Spring, MD 20993, 301-796-5960, FAX: 301-847-8505, email: 
margaret.ames@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 360j), as amended, provides that DGMPAC shall 
be composed of two representatives of interests of the device 
manufacturing industry. The Agency is requesting nominations for a 
nonvoting industry representative on DGMPAC. FDA is publishing a 
separate document announcing the request for notification for voting 
members on DGMPAC.

I. Function of DGMPAC

    DGMPAC reviews proposed regulations issuance regarding good 
manufacturing practices governing the methods used in, and the 
facilities and controls used for, the manufacture, packaging, storage, 
installation, and servicing of devices, and makes 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.

II. Qualifications

    Persons nominated for DGMPAC should possess appropriate 
qualifications to understand and contribute to the committee's work as 
described in the committee's function.

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 FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). 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 the committee. 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 of Food and 
Drugs will select the nonvoting member to represent industry interests.

IV. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Contact information, a current curriculum vitae, and 
the name of the committee of interest should be sent to the FDA 
Advisory Committee Membership Nomination Portal (see ADDRESSES) within 
30 days of publication of this document (see DATES). FDA will forward 
all nominations to the organizations expressing interest in 
participating in the selection process for the committee. (Persons who 
nominate themselves as nonvoting industry representatives will not 
participate in the selection process).
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and, therefore, encourages nominations of 
appropriately qualified candidates from these groups. Specifically, in 
this document, nominations for nonvoting representatives of industry 
interests are encouraged from the device manufacturing industry.
    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.


[[Page 27266]]


    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12326 Filed 6-13-17; 8:45 am]
 BILLING CODE 4164-01-P

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