83 FR 2165 - Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 10 (January 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 10 (January 16, 2018)
| Page Range | 2165-2167 | |
| FR Document | 2018-00551 |
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)] [Notices] [Pages 2165-2167] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00551] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6877] Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards.'' The purpose of the workshop is to present a draft design of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The workshop is intended to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope, a suitable framework and procedures, and requirements to facilitate implementation of an eventual pilot program. The overarching objectives of the ASCA pilot program are to streamline the standards conformity assessment of medical devices and to improve consistency and predictability in the premarket review process where certain FDA recognized standards are used. DATES: The public workshop will be held on May 22 and 23, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by June 29, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 29, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-6877 for ``Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards; Public Workshop; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including [[Page 2166]] the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background As part of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA and industry agreed to establish a Pilot Accreditation Scheme for Conformity Assessment (ASCA) Program for recognizing accredited testing laboratories that evaluate medical devices per certain FDA- recognized standards. Section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d) was amended by adding a new subsection (d) with the title ``Pilot Accreditation Scheme for Conformity Assessment,'' under the FDA Reauthorization Act of 2017 (FDARA). The new section 514(d) authorizes FDA to establish a pilot program under which FDA may select accreditation bodies that can accredit testing laboratories meeting FDA-specified criteria to assess conformance of medical devices to certain FDA-recognized consensus standards under the ASCA pilot program. The goal of this pilot program is to streamline the standards conformity assessment of medical devices during the premarket review process. The objectives of the ASCA pilot include improved consistency and predictability in the premarket review process where certain FDA recognized standards are used. Traditionally, under section 514(c) of the FD&C Act, FDA has been accepting a manufacturer's self-declaration of conformity to an FDA- recognized consensus standard as part of its premarket submission. Since medical devices are increasingly complex and involve high risks to the patients, such self-declaration of conformity is not always sufficient to guarantee safety and performance, especially when deviations from the standard have been introduced. In addition, testing performed by the independent laboratories or the manufacturers themselves to support the self-declaration of conformity varies depending on the standard being used. As a result, reviewers sometimes need to request and review test reports to ensure requirements of the standard have been met. The ASCA pilot program is designed to address such issues through improved quality and increased confidence in the testing labs to achieve a least burdensome and streamlined regulatory process. The purpose of this public workshop is to present a draft design of the ASCA scheme. FDA intends to discuss and obtain input and recommendations from stakeholders on the draft scheme, including its goals and scope, its framework and procedures, and requirements as required per FDARA. Public input and feedback gained through this workshop are also intended to aid in the development of a draft ASCA guidance, which is another MDUFA IV commitment. II. Topics for Discussion at the Public Workshop This public workshop will consist of both plenary presentations and breakout sessions. A keynote presentation is planned to provide high- level background information about standards use and standards conformity assessment (CA) in medical device regulatory processes, major existing CA programs, and significance of and challenges to national and international harmonization in CA. FDA will present background information about the proposed ASCA pilot program, its objectives and plans, what issues it aims to resolve and how. Following the plenary presentations, multiple breakout sessions will be convened. Each breakout session is designed to focus on a major ASCA-related topic. The topics to be discussed include: Performance metrics to measure the success and impact of the ASCA Additional requirements for accrediting bodies beyond the standard (ISO/IEC 17011:2017 Conformity assessment--Requirements for accreditation bodies accrediting conformity assessment bodies, available at https://www.iso.org/standard/67198.html) and for testing organizations beyond the standard (ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories, available at https://www.iso.org/standard/66912.html) Criteria for selection of pilot standards for ASCA Roles that testing organizations can play for ASCA A detailed agenda will be posted on the following website in advance of the workshop: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm; select this event from the list of items provided. The overarching objectives of the ASCA pilot program are to streamline the standards conformity assessment of medical devices, and improve consistency and predictability in the premarket review process where certain FDA recognized standards are used. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select this event from the list of items provided. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by May 14, 2018, 4 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public workshop. [[Page 2167]] If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, Silver Spring, MD 20993-0002, 301-796-5661, or email: [email protected], no later than May 8, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by May 16, 2018, midnight Eastern Time. All requests to make oral presentations must be received by the close of registration on May 14, 2018, 4 p.m. Eastern Time. If selected for presentation, any presentation materials must be emailed to Scott Colburn (see FOR FURTHER INFORMATION CONTACT) no later than May 18, 2018, midnight Eastern Time. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. The webcast link will be available on the registration web page after May 14, 2018. Please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select this event from the list of items provided. Organizations are requested to register all participants, but to view using one connection per location. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Dated: January 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00551 Filed 1-12-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2165
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
Total .............................................................................. ........................ ........................ ........................ ........................ 23,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this assessment of medical devices and to anyone else’s Social Security number, or
information collection has not changed improve consistency and predictability confidential business information, such
since the last OMB approval. in the premarket review process where as a manufacturing process. Please note
This document also refers to certain FDA recognized standards are that if you include your name, contact
previously approved collections of used. information, or other information that
information found in FDA regulations. DATES: The public workshop will be identifies you in the body of your
These collections of information are held on May 22 and 23, 2018, from 9 comments, that information will be
subject to review by OMB under the a.m. to 5 p.m. Submit either electronic posted on https://www.regulations.gov.
PRA (44 U.S.C. 3501–3520). The or written comments on this public • If you want to submit a comment
collections of information found in workshop by June 29, 2018. See the with confidential information that you
§§ 821.2(b), 821.25(e), and 821.30(e) SUPPLEMENTARY INFORMATION section for do not wish to be made available to the
have been approved under OMB control registration date and information. public, submit the comment as a
number 0910–0191. ADDRESSES: The public workshop will written/paper submission and in the
Dated: January 9, 2018. be held at FDA’s White Oak Campus, manner detailed (see ‘‘Written/Paper
Leslie Kux, 10903 New Hampshire Ave., Bldg. 31 Submissions’’ and ‘‘Instructions’’).
Associate Commissioner for Policy. Conference Center, the Great Room (Rm. Written/Paper Submissions
[FR Doc. 2018–00568 Filed 1–12–18; 8:45 am] 1503), Silver Spring, MD 20993.
Entrance for the public workshop Submit written/paper submissions as
BILLING CODE 4164–01–P
participants (non-FDA employees) is follows:
through Building 1 where routine • Mail/Hand delivery/Courier (for
security check procedures will be written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND Management Staff (HFA–305), Food and
HUMAN SERVICES performed. For parking and security
information, please refer to https:// Drug Administration, 5630 Fishers
Food and Drug Administration www.fda.gov/AboutFDA/ Lane, Rm. 1061, Rockville, MD 20852.
WorkingatFDA/BuildingsandFacilities/ • For written/paper comments
[Docket No. FDA–2017–N–6877] submitted to the Dockets Management
WhiteOakCampusInformation/
ucm241740.htm. Staff, FDA will post your comment, as
Accreditation Scheme for Conformity well as any attachments, except for
Assessment of Medical Devices to You may submit comments as
follows. Please note that late, untimely information submitted, marked and
Food and Drug Administration- identified, as confidential, if submitted
Recognized Standards; Public filed comments will not be considered.
Electronic comments must be submitted as detailed in ‘‘Instructions.’’
Workshop; Request for Comments Instructions: All submissions received
on or before June 29, 2018. The https://
AGENCY: Food and Drug Administration, www.regulations.gov electronic filing must include the Docket No. FDA–
HHS. system will accept comments until 2017–N–6877 for ‘‘Accreditation
ACTION: Notice of public workshop; midnight Eastern Time at the end of Scheme for Conformity Assessment of
request for comments. June 29, 2018. Comments received by Medical Devices to FDA-Recognized
mail/hand delivery/courier (for written/ Standards; Public Workshop; Request
SUMMARY: The Food and Drug paper submissions) will be considered for Comments.’’ Received comments,
Administration (FDA, the Agency, or timely if they are postmarked or the those filed in a timely manner (see
we) is announcing the following public delivery service acceptance receipt is on ADDRESSES), will be placed in the docket
workshop entitled ‘‘Accreditation or before that date. and, except for those submitted as
Scheme for Conformity Assessment of ‘‘Confidential Submissions,’’ publicly
Medical Devices to FDA-Recognized Electronic Submissions viewable at https://www.regulations.gov
Standards.’’ The purpose of the Submit electronic comments in the or at the Dockets Management Staff
workshop is to present a draft design of following way: between 9 a.m. and 4 p.m., Monday
the Accreditation Scheme for • Federal eRulemaking Portal: through Friday.
Conformity Assessment (ASCA) pilot https://www.regulations.gov. Follow the • Confidential Submissions—To
program. The workshop is intended to instructions for submitting comments. submit a comment with confidential
discuss and obtain input and Comments submitted electronically, information that you do not wish to be
recommendations from stakeholders on including attachments, to https:// made publicly available, submit your
the draft accreditation scheme, www.regulations.gov will be posted to comments only as a written/paper
daltland on DSKBBV9HB2PROD with NOTICES
including its goals and scope, a suitable the docket unchanged. Because your submission. You should submit two
framework and procedures, and comment will be made public, you are copies total. One copy will include the
requirements to facilitate solely responsible for ensuring that your information you claim to be confidential
implementation of an eventual pilot comment does not include any with a heading or cover note that states
program. The overarching objectives of confidential information that you or a ‘‘THIS DOCUMENT CONTAINS
the ASCA pilot program are to third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The
streamline the standards conformity such as medical information, your or Agency will review this copy, including
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![Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2167
If you need special accommodations accessible at https:// FOR FURTHER INFORMATION CONTACT:
due to a disability, please contact Susan www.regulations.gov. It may be viewed Rohini Khillan (202) 690–5932,
Monahan, Center for Devices and at the Dockets Management Staff (see rohini.khillan@hhs.gov. Note: Seating
Radiological Health, Food and Drug ADDRESSES). A link to the transcript will
may be limited. Those wishing to attend
Administration, 10903 New Hampshire also be available on the internet at the meeting must send an email to
Ave., Bldg. 32, Rm. 5231, Silver Spring, https://www.fda.gov/MedicalDevices/
napa@hhs.gov and put ‘‘January 26
MD 20993–0002, 301–796–5661, or NewsEvents/WorkshopsConferences/
email: Susan.Monahan@fda.hhs.gov, no Meeting Attendance’’ in the Subject line
default.htm.
later than May 8, 2018. by Tuesday, January 16, so that their
Dated: January 9, 2018. names may be put on a list of expected
Requests for Oral Presentations:
Leslie Kux, attendees and forwarded to the security
During online registration you may
indicate if you wish to present during a Associate Commissioner for Policy. officers at the Department of Health and
public comment session or participate [FR Doc. 2018–00551 Filed 1–12–18; 8:45 am] Human Services. Any interested
in a specific session, and which topic(s) BILLING CODE 4164–01–P member of the public who is a non-U.S.
you wish to address. We will do our citizen should include this information
best to accommodate requests to make at the time of registration to ensure that
public comments. Individuals and DEPARTMENT OF HEALTH AND the appropriate security procedure to
organizations with common interests are HUMAN SERVICES gain entry to the building is carried out.
urged to consolidate or coordinate their Although the meeting is open to the
presentations, and request time for a Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting public, procedures governing security
joint presentation, or submit requests for and the entrance to Federal buildings
designated representatives to participate AGENCY: Assistant Secretary for may change without notice. If you wish
in the focused sessions. Following the Planning and Evaluation, HHS. to make a public comment, you must
close of registration, we will determine ACTION: Notice of meeting. note that within your email.
the amount of time allotted to each
presenter and the approximate time SUMMARY: This notice announces the SUPPLEMENTARY INFORMATION: Notice of
each oral presentation is to begin, and public meeting of the Advisory Council these meetings is given under the
will select and notify participants by on Alzheimer’s Research, Care, and Federal Advisory Committee Act (5
May 16, 2018, midnight Eastern Time. Services (Advisory Council). The U.S.C. App. 2, section 10(a)(1) and
All requests to make oral presentations Advisory Council on Alzheimer’s (a)(2)). Topics of the Meeting: During
must be received by the close of Research, Care, and Services provides the January meeting, the Research
registration on May 14, 2018, 4 p.m. advice on how to prevent or reduce the Subcommittee will be taking charge of
Eastern Time. If selected for burden of Alzheimer’s disease and the theme, focusing on the process from
presentation, any presentation materials related dementias on people with the targets to treatments. The Council will
must be emailed to Scott Colburn (see disease and their caregivers. During the hear speakers on the preclinical
FOR FURTHER INFORMATION CONTACT) no January meeting, the Research pipeline, the clinical trial pipeline, and
later than May 18, 2018, midnight Subcommittee will be taking charge of
Eastern Time. No commercial or the industry perspective. The meeting
the theme, focusing on the process from will also include discussion of a driver
promotional material will be permitted targets to treatments. The Council will
to be presented or distributed at the diagram to guide the Council’s future
hear speakers on the preclinical work, updates and a report from the
public workshop. pipeline, the clinical trial pipeline, and
Streaming Webcast of the Public October Care Summit, and federal
the industry perspective. The meeting
Workshop: This public workshop will workgroup updates.
will also include discussion of a driver
also be webcast. The webcast link will diagram to guide the Council’s future Procedure and Agenda: This meeting
be available on the registration web page work, updates and a report from the is open to the public. Please allow 30
after May 14, 2018. Please visit FDA’s October Care Summit, and federal minutes to go through security and walk
Medical Devices News & Events— workgroup updates. to the meeting room. The meeting will
Workshops & Conferences calendar also be webcast at www.hhs.gov/live.
(https://www.fda.gov/MedicalDevices/ DATES: The meeting will be held on
NewsEvents/WorkshopsConferences/ January 26, 2018 from 9:00 a.m. to 5:00 Authority: 42 U.S.C. 11225; Section 2(e)(3)
default.htm) and select this event from p.m. EDT. of the National Alzheimer’s Project Act. The
the list of items provided. Organizations ADDRESSES: The meeting will be held in panel is governed by provisions of Public
are requested to register all participants, Room 800 in the Hubert H. Humphrey Law 92–463, as amended (5 U.S.C. Appendix
but to view using one connection per Building, 200 Independence Avenue 2), which sets forth standards for the
location. SW, Washington, DC 20201. formation and use of advisory committees.
If you have never attended a Connect Comments: Time is allocated in the Dated: January 9, 2018.
Pro event before, test your connection at afternoon on the agenda to hear public John R. Graham,
https://collaboration.fda.gov/common/ comments. The time for oral comments
will be limited to two (2) minutes per Acting Assistant Secretary for Planning and
help/en/support/meeting_test.htm. To
Evaluation.
get a quick overview of the Connect Pro individual. In lieu of oral comments,
formal written comments may be [FR Doc. 2018–00480 Filed 1–12–18; 8:45 am]
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has submitted for the record to Rohini BILLING CODE 4150–05–P
daltland on DSKBBV9HB2PROD with NOTICES
verified the website addresses in this Khillan, OASPE, 200 Independence
document, as of the date this document Avenue SW, Room 424E, Washington,
publishes in the Federal Register, but DC 20201. Comments may also be sent
websites are subject to change over time. to napa@hhs.gov. Those submitting
Transcripts: Please be advised that as written comments should identify
soon as a transcript of the public themselves and any relevant
workshop is available, it will be organizational affiliations.
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Document Created: 2018-01-13 02:02:38
Document Modified: 2018-01-13 02:02:38
| 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 of public workshop; request for comments. | |
| Dates | The public workshop will be held on May 22 and 23, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by June 29, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287, [email protected] | |
| FR Citation | 83 FR 2165 |
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