82 FR 27265 - Request for Nominations on Device Good Manufacturing Practice Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 113 (June 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 113 (June 14, 2017)
| Page Range | 27265-27266 | |
| FR Document | 2017-12326 |
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)] [Notices] [Pages 27265-27266] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12326] ----------------------------------------------------------------------- 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: [email protected]. 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
![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27265
379,493, or 18,975 firms. Thus, we nominations should be sent to Margaret III. Selection Procedure
estimate that approximately 18,975 Ames (see FOR FURTHER INFORMATION
facilities will spend 4.790 hours CONTACT). All nominations for Any industry organization interested
learning about the recordkeeping and nonvoting industry representatives in participating in the selection of an
records access requirements, for a total should be submitted electronically by appropriate nonvoting member to
of 90,890 hours annually. We estimate accessing FDA’s Advisory Committee represent industry interests should send
that approximately the same number of Membership Nomination Portal at a letter stating that interest to the FDA
firms (18,975) will exit the affected https://www.accessdata.fda.gov/scripts/ contact (see FOR FURTHER INFORMATION
businesses in any given year, resulting FACTRSPortal/FACTRS/index.cfm or by CONTACT) within 30 days of publication
in no growth in the number of total mail to Advisory Committee Oversight of this document (see DATES). Within the
firms reported on line 1 of table 1. and Management Staff, Food and Drug subsequent 30 days, FDA will send a
Therefore, the total annual Administration, 10903 New Hampshire letter to each organization that has
recordkeeping burden is estimated to be Ave., Bldg. 32, Rm. 5103, Silver Spring, expressed an interest, attaching a
5,110,890 hours. MD 20993–0002. Information about complete list of all such organizations,
Dated: June 9, 2017. becoming a member of an FDA advisory and a list of all nominees along with
Anna K. Abram,
committee can also be obtained by their current resumes. The letter will
visiting FDA’s Web site at https:// also state that it is the responsibility of
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
www.fda.gov/AdvisoryCommittees/ the interested organizations to confer
default.htm. with one another and to select a
[FR Doc. 2017–12327 Filed 6–13–17; 8:45 am]
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: candidate, within 60 days after the
Margaret Ames, Office of Management, receipt of the FDA letter, to serve as the
Center for Devices and Radiological nonvoting member to represent industry
DEPARTMENT OF HEALTH AND Health, Food and Drug Administration, interests for the committee. The
HUMAN SERVICES 10903 New Hampshire Ave., Bldg. 66, interested organizations are not bound
Rm. 5264, Silver Spring, MD 20993, by the list of nominees in selecting a
Food and Drug Administration 301–796–5960, FAX: 301–847–8505, candidate. However, if no individual is
[Docket No. FDA–2017–N–2463] email: margaret.ames@fda.hhs.gov. selected within the 60 days, the
SUPPLEMENTARY INFORMATION: Section Commissioner of Food and Drugs will
Request for Nominations on Device 520 of the Federal Food, Drug and select the nonvoting member to
Good Manufacturing Practice Advisory Cosmetic Act (21 U.S.C. 360j), as represent industry interests.
Committee amended, provides that DGMPAC shall
be composed of two representatives of IV. Application Procedure
AGENCY: Food and Drug Administration,
interests of the device manufacturing
HHS. Individuals may self-nominate and/or
industry. The Agency is requesting
ACTION: Notice. nominations for a nonvoting industry an organization may nominate one or
representative on DGMPAC. FDA is more individuals to serve as a nonvoting
SUMMARY: The Food and Drug industry representative. Contact
Administration (FDA) is requesting that publishing a separate document
announcing the request for notification information, a current curriculum vitae,
any industry organization interested in and the name of the committee of
participating in the selection of a for voting members on DGMPAC.
interest should be sent to the FDA
nonvoting industry representative to I. Function of DGMPAC Advisory Committee Membership
serve on the Device Good
DGMPAC reviews proposed Nomination Portal (see ADDRESSES)
Manufacturing Practice Advisory
regulations issuance regarding good within 30 days of publication of this
Committee (DGMPAC) in the Center for
manufacturing practices governing the document (see DATES). FDA will forward
Devices and Radiological Health notify
methods used in, and the facilities and all nominations to the organizations
FDA in writing. FDA is also requesting
controls used for, the manufacture, expressing interest in participating in
nominations for a nonvoting industry
packaging, storage, installation, and the selection process for the committee.
representative to serve on DGMPAC. A
servicing of devices, and makes (Persons who nominate themselves as
nominee may either be self-nominated
recommendations regarding the nonvoting industry representatives will
or nominated by an organization to
feasibility and reasonableness of those not participate in the selection process).
serve as a nonvoting industry
proposed regulations. The committee
representative. Nominations will be FDA seeks to include the views of
also reviews and makes
accepted for the upcoming vacancy women and men, members of all racial
recommendations on proposed
effective with this notice. and ethnic groups, and individuals with
guidelines developed to assist the
DATES: Any industry organizations medical device industry in meeting the and without disabilities on its advisory
interested in participating in the good manufacturing practice committees and, therefore, encourages
selection of an appropriate nonvoting requirements, and provides advice with nominations of appropriately qualified
member to represent industry interests regard to any petition submitted by a candidates from these groups.
must send a letter stating that interest to manufacturer for an exemption or Specifically, in this document,
FDA by July 14, 2017 (see sections I and variance from good manufacturing nominations for nonvoting
III of this document for further details). practice regulations.
mstockstill on DSK30JT082PROD with NOTICES
representatives of industry interests are
Concurrently, nomination materials for encouraged from the device
prospective candidates should be sent to II. Qualifications
manufacturing industry.
FDA by July 14, 2017. Persons nominated for DGMPAC
ADDRESSES: All statements of interest should possess appropriate This notice is issued under the
from industry organizations interested qualifications to understand and Federal Advisory Committee Act (5
in participating in the selection process contribute to the committee’s work as U.S.C. app. 2) and 21 CFR part 14,
of nonvoting industry representative described in the committee’s function. relating to advisory committees.
VerDate Sep<11>2014 17:36 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/82_FR_27378/page/1.svg)
![27266 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
Dated: June 9, 2017. Hampshire Ave., Bldg. 66, Rm. G616, advisory committee for which the
Anna K. Abram, Silver Spring, MD 20993, 301–796– nominee is recommended. Nominations
Deputy Commissioner for Policy, Planning, 7047, email: Sara.Anderson@ must also acknowledge that the
Legislation, and Analysis. fda.hhs.gov. nominee is aware of the nomination
[FR Doc. 2017–12326 Filed 6–13–17; 8:45 am] SUPPLEMENTARY INFORMATION: FDA is unless self-nominated. FDA will ask
BILLING CODE 4164–01–P requesting nominations for voting potential candidates to provide detailed
members on the National information concerning such matters
Mammography Quality Assurance related to financial holdings,
DEPARTMENT OF HEALTH AND Advisory Committee. employment, and research grants and/or
HUMAN SERVICES contracts to permit evaluation of
I. General Description of the Committee possible sources of conflict of interest.
Food and Drug Administration Duties This notice is issued under the
[Docket No. FDA–2017–N–0001] The National Mammography Quality Federal Advisory Committee Act (5
Assurance Advisory Committee advises U.S.C. app. 2) and 21 CFR part 14,
Request for Nominations of Voting the Commissioner of Food and Drugs relating to advisory committees.
Members on a Public Advisory (the Commissioner) or designee on: (1) Dated: June 9, 2017.
Committee; National Mammography Developing appropriate quality Anna K. Abram,
Quality Assurance Advisory standards and regulations for
Deputy Commissioner for Policy, Planning,
Committee mammography facilities; (2) developing Legislation, and Analysis.
appropriate standards and regulations
AGENCY: Food and Drug Administration, [FR Doc. 2017–12312 Filed 6–13–17; 8:45 am]
for bodies accrediting mammography
HHS. facilities under this program; (3) BILLING CODE 4164–01–P
ACTION: Notice. developing regulations with respect to
sanctions; (4) developing procedures for
SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND
monitoring compliance with standards;
Administration (FDA) is requesting HUMAN SERVICES
(5) establishing a mechanism to
nominations for voting members to
investigate consumer complaints; (6) Food and Drug Administration
serve on the National Mammography
reporting new developments concerning
Quality Assurance Advisory Committee [Docket Nos. FDA–2015–E–0635; FDA–
breast imaging that should be
in the Center for Devices and 2015–E–0634; FDA–2015–E–0629]
considered in the oversight of
Radiological Health. FDA seeks to
mammography facilities; (7)
include the views of women and men, Determination of Regulatory Review
determining whether there exists a
members of all racial and ethnic groups, Period for Purposes of Patent
shortage of mammography facilities in
and individuals with and without Extension; NEUROPACE RNS SYSTEM
rural and health professional shortage
disabilities on its advisory committees areas and determining the effects of AGENCY: Food and Drug Administration,
and, therefore, encourages nominations personnel on access to the services of HHS.
of appropriately qualified candidates such facilities in such areas; (8)
from these groups. ACTION: Notice.
determining whether there will exist a
DATES: Nominations received on or sufficient number of medical physicists SUMMARY: The Food and Drug
before August 14, 2017, will be given after October 1, 1999; and (9) Administration (FDA) has determined
first consideration for membership on determining the costs and benefits of the regulatory review period for
the National Mammography Quality compliance with these requirements. NEUROPACE RNS SYSTEM and is
Assurance Advisory Committee. publishing this notice of that
Nominations received after August 14, II. Criteria for Voting Members
determination as required by law. FDA
2017, will be considered for nomination The committee consists of a core of 15 has made the determination because of
to the committee as later vacancies members, including the Chair. Members the submission of applications to the
occur. and the Chair are selected by the Director of the U.S. Patent and
ADDRESSES: All nominations for Commissioner or designee from among Trademark Office (USPTO), Department
membership should be submitted physicians, practitioners, and other of Commerce, for the extension of a
electronically by logging into the FDA health professionals, whose clinical patent which claims that medical
Advisory Nomination Portal: http:// practice, research specialization, or device.
www.accessdata.fda.gov/scripts/ professional expertise includes a
significant focus on mammography. DATES: Anyone with knowledge that any
FACTRSPortal/FACTRS/index.cfm or by of the dates as published (see the
mail to Advisory Committee Oversight Almost all non-Federal members of this
SUPPLEMENTARY INFORMATION section) are
and Management Staff, Food and Drug committee serve as Special Government
Employees. Members will be invited to incorrect may submit either electronic
Administration, 10903 New Hampshire or written comments and ask for a
Ave., Bldg. 32, Rm. 5103, Silver Spring, serve for terms of up to 4 years.
redetermination by August 14, 2017.
MD 20993–0002. Information about III. Nomination Procedures Furthermore, any interested person may
becoming a member on an FDA advisory Any interested person may nominate petition FDA for a determination
committee can also be obtained by one or more qualified persons for regarding whether the applicant for
visiting FDA’s Web site at http:// membership on the advisory committee. extension acted with due diligence
mstockstill on DSK30JT082PROD with NOTICES
www.fda.gov/AdvisoryCommittees/ Self-nominations are also accepted. during the regulatory review period by
default.htm. Nominations must include a current, December 11, 2017. See ‘‘Petitions’’ in
FOR FURTHER INFORMATION CONTACT: complete resume or curriculum vitae for the SUPPLEMENTARY INFORMATION section
Regarding all nomination questions for each nominee, including current for more information.
membership: Sara Anderson, Center for business address and/or home address, ADDRESSES: You may submit comments
Devices and Radiological Health, Food telephone number, and email address if as follows. Please note that late,
and Drug Administration, 10903 New available. Nominations must specify the untimely filed comments will not be
VerDate Sep<11>2014 17:36 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/82_FR_27378/page/2.svg)
Document Created: 2017-06-14 01:23:34
Document Modified: 2017-06-14 01:23:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | 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. | |
| 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: [email protected] | |
| FR Citation | 82 FR 27265 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR