
[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Notices]
[Pages 25875-25876]
From the Federal Register Online via the Government Printing 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: 
Catherine.norcio@fda.hhs.gov.
    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: 
susan.monahan@fda.hhs.gov) 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


