[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Notices]
[Pages 25875-25876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10262]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0530]
Center for Devices and Radiological Health Guidance Development
and Prioritization; Public Workshop; Requests for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Center for Devices and Radiological Health
Guidance Development and Prioritization Public Workshop.'' The topics
to be discussed include the FDA's Center for Devices and Radiological
Health's (CDRH) guidance development process, guidance development best
practices for FDA, CDRH, and CDRH stakeholders, and CDRH guidance
priorities and priority development.
Date and Time: The public workshop will be held on June 5, 2014,
from 9 a.m. to 3 p.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503A), Silver Spring, MD 20993-0002. Entrance for 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Cathy Norcio, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5448, Silver Spring, MD 20993-0002, 301-796-5446, email:
[email protected].
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 5 p.m., EDT, May 29, 2014. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the workshop will be provided beginning at 8 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan (301-796-5661 or email:
[email protected]) no later than May 22, 2014.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, email, and telephone number. Those without Internet
access should contact Susan Monahan to register (see Registration
contact for special accommodations). Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 5 p.m., EDT, May 29, 2014. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information no later than June 2, 2014. 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 http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Comments: FDA is holding this public workshop to obtain feedback on
CDRH's guidance development and guidance prioritization processes. In
order to permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the public workshop topics. The deadline for submitting
comments related to this public workshop is July 7, 2014.
Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Please identify comments with the docket number found in
brackets in the heading of this document. Received comments may be
viewed in person in the Division of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and will be posted to the docket at
http://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
SUPPLEMENTARY INFORMATION:
I. Background
Guidance documents are documents issued by FDA and prepared for FDA
staff and/or FDA stakeholders. They describe the Agency's
interpretation of, or policy on, a regulatory issue (see Sec.
10.115(b) (21 CFR 10.115(b))). Unlike statutes and regulations,
guidances themselves do not create legally binding requirements (see
Sec. 10.115(d)). Nevertheless, guidance documents are important
because they assist both staff and industry in understanding FDA's
current thinking on certain topics. FDA's Good Guidance Practices
regulation (Sec. 10.115) governs the development and issuance of
guidance, and it gives interested parties a number
[[Page 25876]]
of opportunities to provide input into the guidance development
process. Interested parties may provide input by:
(1) Submitting Comments on Guidance Topics Listed in CDRH's
Proposed Guidance Development lists: FDA announces annually in the
Federal Register the Web site location where the Agency posts lists of
prioritized medical device guidance documents that CDRH intends to
publish in the fiscal year. This information for fiscal year 2014 may
be found in the Federal Register at 78 FR 66746 (November 6, 2013) and
on the Internet at http://www.gpo.gov/fdsys/pkg/FR-2013-11-06/pdf/2013-26547.pdf and at http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/mdufaiii/ucm321367.htm. In
addition, FDA establishes a docket where CDRH invites interested
persons to submit comments on any or all of the guidance documents
identified in the annual Proposed Guidance Development lists. Comments
may include draft language on the proposed topics, suggestions for new
or different guidance documents, and/or the relative priority of
guidance documents.
(2) Submitting Proposed Draft Guidance to FDA for Consideration:
Submitting proposed draft guidance, rather than a guidance topic,
enables FDA to review and consider a fully developed approach to an
issue of interest to a stakeholder. FDA may then adopt that approach,
in full or in part, in a draft guidance that would be issued for public
comment. This process holds the potential to shorten the total time for
guidance development and facilitate consensus on novel, complex, or
controversial issues. FDA solicits proposed draft guidances at a
variety of different venues, such as trade association meetings and on
the FDA Web site. Interested parties may submit proposed draft
guidances on unsolicited topics, as well. While some stakeholders have
developed proposed draft guidances for FDA's consideration, few have
used this approach.
(3) Commenting on Draft Level 1 Guidance: Generally, FDA solicits
public input on Level 1 guidances prior to implementation. The Agency
posts draft Level 1 guidances on its Web site, and it publicizes the
draft guidance by issuing a notice of availability (NOA) in the Federal
Register. Generally, the Agency requests that public comments on the
guidance be provided within 60 days of publication of the draft
guidance. Once the comment period has closed, the Agency reviews the
comments and considers them as it finalizes the policy at issue and
publishes the final guidance. The Agency posts the final Level 1
guidance on its Web site and publicizes the final guidance by
publishing an NOA in the Federal Register. In some instances, FDA may
hold public meetings or workshops prior to issuing a draft Level 1
guidance or after issuing the draft but prior to finalizing the
guidance to solicit additional comments or perspectives on the policy
at issue.
(4) Commenting on Level 2 Guidance and Level 1 Immediately in
Effect Guidance: Generally, FDA does not solicit public input on Level
2 guidance or on Level 1 Immediately in Effect guidance prior to
implementing the guidance. Level 2 guidance documents are guidance
documents that set forth existing practices or minor changes in
interpretation or policy (Sec. 10.115(c)(2)) Level 1 Immediately in
Effect guidances are issued when prior public participation is not
feasible or appropriate (Sec. 10.115(g)(2)). However, FDA posts both
types of guidance on its Web site, and interested parties may comment
on them at any time after they have been issued. FDA will review the
comments and revise the guidances, as appropriate. These streamlined
options permit FDA to issue guidance more expeditiously than standard
Level 1 guidance, while still providing stakeholders with an
opportunity to comment. The additional administrative steps required
for standard Level 1 guidance (i.e., issuing draft guidance, providing
a comment period, and issuing final guidance) generally make the
issuance of standard Level 1 guidance a longer process.
(5) Suggesting that FDA Revise or Withdraw an Existing Guidance
Document: The Agency accepts and considers suggestions for revising or
withdrawing existing guidance documents at any time. FDA is committed
to updating its Web site in a timely manner to reflect the Agency's
review of previously issued guidance documents, including the deletion
of guidance documents that no longer represent the Agency's
interpretation of, or policy on, a regulatory issue. CDRH encourages
stakeholders to provide information concerning why a guidance should be
revised or withdrawn, and, if applicable, provide comments about how a
guidance should be revised.
This public workshop and the opening of a docket requesting
comments and suggestions provide stakeholders with an additional
opportunity to actively engage with CDRH regarding the level of public
participation and other best practices in guidance development as well
as how CDRH should develop its guidance priorities. To facilitate
transparency, the workshop will also include information about the
development and practical implementation of CDRH's internal guidance
development process. CDRH encourages collaborative efforts with the
public in the development of guidance documents and believes this
workshop will help advance these efforts. CDRH is committed to
exploring ways to facilitate stakeholder participation in guidance
development within the confines of applicable statutes and regulations,
considering the need to provide all interested parties access to the
process, issuing documents in a timely manner, and balancing internal
resources effectively to accomplish its public health mission.
II. Topics for Discussion at the Public Workshop
The topics to be discussed include CDRH's guidance development
process, guidance development best practices for FDA, CDRH, and CDRH
stakeholders, and CDRH guidance priorities and priority development.
Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10262 Filed 5-5-14; 8:45 am]
BILLING CODE 4160-01-P