Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development, 58429-58431 [2017-26721]

Download as PDF Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Written/Paper Submissions [Docket No. FDA–2012–N–1021] Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that CDRH (or the Center) intends to publish in fiscal year (FY) 2018. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs. DATES: Submit either electronic or written comments by February 12, 2018. ADDRESSES: You may submit comments as follows: ethrower on DSK3G9T082PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 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– 2012–N–1021 for ‘‘Notice to Public of Website Location of CDRH Fiscal Year 2018 Proposed Guidance Development.’’ Received comments 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 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 58429 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: Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993–0002, 301–796–6353. SUPPLEMENTARY INFORMATION: I. Background During negotiations on the Medical Device User Fee Amendments of 2012 (MDUFA III), Title II, Food and Drug Administration Safety and Innovation Act (Pub. L. 112–114), FDA agreed to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among these commitments included: • Annually posting a list of priority medical device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (the ‘‘A-list’’), and • Annually posting a list of device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each fiscal year (the ‘‘B-list’’). The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA Reauthorization Act of 2017 (Pub. L. 115–52) maintained these commitments. FDA welcomes comments on any or all of the guidance documents on the lists as explained in 21 CFR 10.115(f)(5). FDA has established Docket No. FDA– 2012–N–1021 where comments on the FY 2018 lists, draft language for guidance documents on those topics, suggestions for new or different guidances, and relative priority of guidance documents may be submitted and shared with the public (see ADDRESSES). FDA believes this docket is a valuable tool for receiving information from interested persons and will update these lists after considering public comments, where appropriate. FDA anticipates that feedback from interested persons will allow CDRH to better prioritize and more efficiently draft guidances to meet the needs of the Agency and our stakeholders. In addition to posting the lists of prioritized device guidance documents, E:\FR\FM\12DEN1.SGM 12DEN1 58430 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices FDA has committed to updating its website in a timely manner to reflect the Agency’s review of previously published guidance documents, including the deletion of guidance documents that no longer represent the Agency’s interpretation of or policy on a regulatory issue. Fulfillment of these commitments will be reflected through the issuance of updated guidance on existing topics, removal of guidances that no longer reflect FDA’s current thinking on a particular topic, and annual updates to the A-list and B-list announced in this notice. II. CDRH Guidance Development Initiatives A. Finalization of Draft Guidance Documents CDRH has identified as a priority, and has devoted resources to, finalization of draft guidance documents. To assure the timely completion or re-issuance of draft guidances, in FY 2015 CDRH committed to performance goals for current and future draft guidance documents. For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, re-open the comment period, or issue new draft guidance on the topic for 80 percent of the documents within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years. As part of MDUFA IV commitments, FDA reaffirmed this commitment, as resources permit. In addition, in FY 2017, CDRH withdrew 4 of 8 draft guidances issued prior to October 1, 2011, and has been continuing to work towards taking an action on the remaining draft guidances. Looking forward, in FY 2018, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2012. ethrower on DSK3G9T082PROD with NOTICES B. Earlier Stakeholder Involvement in Guidance Development CDRH has received feedback that stakeholders desire earlier involvement in the guidance process and has taken steps to create a mechanism to address this request. In FY 2016, in anticipation of guidance documents expected to be developed, CDRH sought stakeholder input regarding electromagnetic compatibility of electrically powered medical devices and regarding utilizing animal studies to evaluate the safety of organ preservation devices and solutions. FDA appreciated the feedback received and considered it in the development of these guidances. Demonstrating commitment to VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 incorporating stakeholder input, CDRH issued a draft guidance in FY17 on utilizing animal studies to evaluate the safety of organ preservation devices, and is progressing toward issuance of draft policies reflecting early stakeholder input as appropriate. FDA also welcomes any additional feedback for improving the guidance program and the quality of CDRH guidance documents. C. Applicability of Previously Issued Final Guidance CDRH has issued over 600 final guidance documents to provide stakeholders with the Agency’s thinking on numerous topics. Each guidance reflected the Agency’s current position at the time that it was issued. However, the guidance program has issued these guidances over a period of 30 years, raising the question of how current previously issued final guidances remain. CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders. At the website where CDRH has posted the ‘‘Alist’’ and ‘‘B-list’’ for FY 2018, CDRH has also posted a list of final guidance documents that issued in 2008, 1998, 1988, and 1978.1 CDRH is interested in external feedback on whether any of these final guidances should be revised or withdrawn. In addition, for guidances that are recommended for revision, information explaining the need for revision, such as the impact and risk to public health associated with not revising the guidance, would also be helpful as the Center considers potential action with respect to these guidances. CDRH intends to provide these lists of previously issued final guidances annually through FY 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. For instance, in the annual notice for FY 2019, CDRH expects to provide a list of the final guidance documents that issued in 2009, 1999, 1989, and 1979; the annual notice for FY 2020 is expected to provide a list of the final guidance documents that issued in 2010, 2000, 1990, and 1980, and so on. CDRH will consider the comments received from this retrospective review when determining priorities for 1 The retrospective list of final guidances does not include the following: (1) Documents that are not guidances but were inadvertently categorized as guidance such as scientific publications, advisory opinions, and interagency agreements; (2) guidances actively being revised by CDRH; and (3) special controls documents. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 updating guidance documents and will revise these as resources permit. In FY 2017, CDRH received comments regarding guidances issued in 2007, 1997, and 1987, and has withdrawn 32 guidance documents in response to comments received and because these guidance documents were determined to no longer represent the Agency’s current thinking. The revision of several guidance documents is also being considered as resources permit. Consistent with the Good Guidance Practices regulation at 21 CFR 10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or withdraw an already existing guidance document. We request that the suggestion clearly explain why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. While we are requesting feedback on the list of previously issued final guidances located in the annual agenda website, feedback on any guidance is appreciated and will be considered. III. Website Location of Guidance Lists This notice announces the website location of the document that provides the A and B lists of guidance documents, which CDRH is intending to publish during FY 2018. To access these two lists, visit FDA’s website at https:// www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm580172.htm. We note that the topics on this and past guidance priority lists may be removed or modified based on current priorities, as well as comments received regarding these lists. Furthermore, FDA and CDRH priorities are subject to change at any time (e.g., newly identified safety issues). The Agency is not required to publish every guidance on either list if the resources needed would be to the detriment of meeting quantitative review timelines and statutory obligations. In addition, the Agency is not precluded from issuing guidance documents that are not on either list. Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2017 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2017, CDRH issued 9 of 27 guidances on the FY 2017 list (6 from the A-list, 3 from the B-list). At this time, CDRH has decided not to pursue several guidances that were on the FY 2017 A or B list, due to factors including feedback from industry. E:\FR\FM\12DEN1.SGM 12DEN1 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Dated: December 7, 2017. Leslie Kux, Associate Commissioner for Policy. Secretary, Department of Health and Human Services. ACTION: Notice. [FR Doc. 2017–26721 Filed 12–11–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Chronic Fatigue Syndrome Advisory Committee; Amendment Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice; amendment. AGENCY: A notice was published in the Federal Register on November 27, 2017, announcing an in-person meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) on Wednesday, December 13, 2017, from 9:00 a.m. until 3:30 p.m. and Thursday, December 14, 2017, from 9:00 a.m. until 5:00 p.m. The meeting will be held at the U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Room 800, 200 Independence Avenue SW, Washington, DC 20201. The notice is being amended to provide security procedures to enter the Hubert H. Humphrey Building. Individuals interested in attending the meeting in person need to show a state or federal government issued I.D. with a photograph. Individuals can also email the CFSAC inbox (cfsac@hhs.gov) in order to have their names added to a list of attendees. However, it is still necessary for individuals to present a photo I.D. to gain entrance to Hubert H. Humphrey Building. All participants will be escorted to the meeting room. Space is limited. FOR FURTHER INFORMATION CONTACT: CDR Gustavo Ceinos, 202–690–7650; Email address: cfsac@hhs.gov. SUMMARY: Dated: December 6, 2017. Gustavo Ceinos, CDR, USPHS, Designated Federal Officer, Chronic Fatigue Syndrome Advisory Committee. [FR Doc. 2017–26739 Filed 12–11–17; 8:45 am] ethrower on DSK3G9T082PROD with NOTICES BILLING CODE 4150–42–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on Combating AntibioticResistant Bacteria Office of the Assistant Secretary for Health, Office of the AGENCY: VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held on January 24, 2018, of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Preregistration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/ash/ carb/ and must be completed by January 15, 2018; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/ ash/carb/ on the Meetings page. DATES: The meeting is scheduled to be held on January 24, 2018, from 9:00 a.m. to 5:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the website for the Advisory Council at http://www.hhs.gov/ash/ carb/ when this information becomes available. Pre-registration for attending the meeting in person is required to be completed no later than January 15, 2018; public attendance at the meeting is limited to the available space. ADDRESSES: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, DC 20201. The meeting can also be accessed through a live webcast on the day of the meeting. For more information, visit http://www.hhs.gov/ash/carb/. FOR FURTHER INFORMATION CONTACT: Jomana Musmar, Acting Designated Federal Officer, Presidential Advisory Council on Combating AntibioticResistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Avenue SW, Room 715H, Washington, DC 20201. Phone: (202) 690–5566; email: CARB@hhs.gov. SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the SUMMARY: BILLING CODE 4164–01–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 58431 Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92–463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees. The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Advisory Council shall function solely for advisory purposes. In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibioticresistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-todate information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance. The public meeting will be dedicated to two main activities. The Advisory Council will deliberate and vote on a letter drafted by the Immediate Action Subcommittee. The remainder of the day will be focused on the topic of antibiotic stewardship in food and companion animals. The meeting agenda will be posted on the Advisory Council website at http://www.hhs.gov/ ash/carb/ when it has been finalized. All agenda items are tentative and subject to change. Public attendance at the meeting is limited to the available space. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Advisory Council at the address/telephone number listed above at least one week prior to the meeting. For those unable to attend in person, a E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58429-58431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26721]



[[Page 58429]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]


Notice to Public of Website Location of Center for Devices and 
Radiological Health Fiscal Year 2018 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the website location where the Agency will post two lists of 
guidance documents that CDRH (or the Center) intends to publish in 
fiscal year (FY) 2018. In addition, FDA has established a docket where 
interested persons may comment on the priority of topics for guidance, 
provide comments and/or propose draft language for those topics, 
suggest topics for new or different guidance documents, comment on the 
applicability of guidance documents that have issued previously, and 
provide any other comments that could benefit the CDRH guidance program 
and its engagement with stakeholders. This feedback is critical to the 
CDRH guidance program to ensure that we meet stakeholder needs.

DATES: Submit either electronic or written comments by February 12, 
2018.

ADDRESSES: You may submit comments as follows:

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-2012-N-1021 for ``Notice to Public of Website Location of CDRH 
Fiscal Year 2018 Proposed Guidance Development.'' Received comments 
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 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.gpo.gov/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: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of 
2012 (MDUFA III), Title II, Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-114), FDA agreed to meet a variety of 
quantitative and qualitative goals intended to help get safe and 
effective medical devices to market more quickly. Among these 
commitments included:
     Annually posting a list of priority medical device 
guidance documents that the Agency intends to publish within 12 months 
of the date this list is published each fiscal year (the ``A-list''), 
and
     Annually posting a list of device guidance documents that 
the Agency intends to publish, as the Agency's guidance-development 
resources permit each fiscal year (the ``B-list'').
    The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA 
Reauthorization Act of 2017 (Pub. L. 115-52) maintained these 
commitments.
    FDA welcomes comments on any or all of the guidance documents on 
the lists as explained in 21 CFR 10.115(f)(5). FDA has established 
Docket No. FDA-2012-N-1021 where comments on the FY 2018 lists, draft 
language for guidance documents on those topics, suggestions for new or 
different guidances, and relative priority of guidance documents may be 
submitted and shared with the public (see ADDRESSES). FDA believes this 
docket is a valuable tool for receiving information from interested 
persons and will update these lists after considering public comments, 
where appropriate. FDA anticipates that feedback from interested 
persons will allow CDRH to better prioritize and more efficiently draft 
guidances to meet the needs of the Agency and our stakeholders.
    In addition to posting the lists of prioritized device guidance 
documents,

[[Page 58430]]

FDA has committed to updating its website in a timely manner to reflect 
the Agency's review of previously published guidance documents, 
including the deletion of guidance documents that no longer represent 
the Agency's interpretation of or policy on a regulatory issue.
    Fulfillment of these commitments will be reflected through the 
issuance of updated guidance on existing topics, removal of guidances 
that no longer reflect FDA's current thinking on a particular topic, 
and annual updates to the A-list and B-list announced in this notice.

II. CDRH Guidance Development Initiatives

A. Finalization of Draft Guidance Documents

    CDRH has identified as a priority, and has devoted resources to, 
finalization of draft guidance documents. To assure the timely 
completion or re-issuance of draft guidances, in FY 2015 CDRH committed 
to performance goals for current and future draft guidance documents. 
For draft guidance documents issued after October 1, 2014, CDRH 
committed to finalize, withdraw, re-open the comment period, or issue 
new draft guidance on the topic for 80 percent of the documents within 
3 years of the close of the comment period and for the remaining 20 
percent, within 5 years. As part of MDUFA IV commitments, FDA 
reaffirmed this commitment, as resources permit. In addition, in FY 
2017, CDRH withdrew 4 of 8 draft guidances issued prior to October 1, 
2011, and has been continuing to work towards taking an action on the 
remaining draft guidances. Looking forward, in FY 2018, CDRH will 
strive to finalize, withdraw, or re-open the comment period for 50 
percent of existing draft guidances issued prior to October 1, 2012.

B. Earlier Stakeholder Involvement in Guidance Development

    CDRH has received feedback that stakeholders desire earlier 
involvement in the guidance process and has taken steps to create a 
mechanism to address this request. In FY 2016, in anticipation of 
guidance documents expected to be developed, CDRH sought stakeholder 
input regarding electromagnetic compatibility of electrically powered 
medical devices and regarding utilizing animal studies to evaluate the 
safety of organ preservation devices and solutions. FDA appreciated the 
feedback received and considered it in the development of these 
guidances. Demonstrating commitment to incorporating stakeholder input, 
CDRH issued a draft guidance in FY17 on utilizing animal studies to 
evaluate the safety of organ preservation devices, and is progressing 
toward issuance of draft policies reflecting early stakeholder input as 
appropriate.
    FDA also welcomes any additional feedback for improving the 
guidance program and the quality of CDRH guidance documents.

C. Applicability of Previously Issued Final Guidance

    CDRH has issued over 600 final guidance documents to provide 
stakeholders with the Agency's thinking on numerous topics. Each 
guidance reflected the Agency's current position at the time that it 
was issued. However, the guidance program has issued these guidances 
over a period of 30 years, raising the question of how current 
previously issued final guidances remain. CDRH has resolved to address 
this concern through a staged review of previously issued final 
guidances in collaboration with stakeholders. At the website where CDRH 
has posted the ``A-list'' and ``B-list'' for FY 2018, CDRH has also 
posted a list of final guidance documents that issued in 2008, 1998, 
1988, and 1978.\1\ CDRH is interested in external feedback on whether 
any of these final guidances should be revised or withdrawn. In 
addition, for guidances that are recommended for revision, information 
explaining the need for revision, such as the impact and risk to public 
health associated with not revising the guidance, would also be helpful 
as the Center considers potential action with respect to these 
guidances. CDRH intends to provide these lists of previously issued 
final guidances annually through FY 2025 so that by 2025, FDA and 
stakeholders will have assessed the applicability of all guidances 
older than 10 years. For instance, in the annual notice for FY 2019, 
CDRH expects to provide a list of the final guidance documents that 
issued in 2009, 1999, 1989, and 1979; the annual notice for FY 2020 is 
expected to provide a list of the final guidance documents that issued 
in 2010, 2000, 1990, and 1980, and so on. CDRH will consider the 
comments received from this retrospective review when determining 
priorities for updating guidance documents and will revise these as 
resources permit.
---------------------------------------------------------------------------

    \1\ The retrospective list of final guidances does not include 
the following: (1) Documents that are not guidances but were 
inadvertently categorized as guidance such as scientific 
publications, advisory opinions, and interagency agreements; (2) 
guidances actively being revised by CDRH; and (3) special controls 
documents.
---------------------------------------------------------------------------

    In FY 2017, CDRH received comments regarding guidances issued in 
2007, 1997, and 1987, and has withdrawn 32 guidance documents in 
response to comments received and because these guidance documents were 
determined to no longer represent the Agency's current thinking. The 
revision of several guidance documents is also being considered as 
resources permit.
    Consistent with the Good Guidance Practices regulation at 21 CFR 
10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or 
withdraw an already existing guidance document. We request that the 
suggestion clearly explain why the guidance document should be revised 
or withdrawn and, if applicable, how it should be revised. While we are 
requesting feedback on the list of previously issued final guidances 
located in the annual agenda website, feedback on any guidance is 
appreciated and will be considered.

III. Website Location of Guidance Lists

    This notice announces the website location of the document that 
provides the A and B lists of guidance documents, which CDRH is 
intending to publish during FY 2018. To access these two lists, visit 
FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.htm. We note 
that the topics on this and past guidance priority lists may be removed 
or modified based on current priorities, as well as comments received 
regarding these lists. Furthermore, FDA and CDRH priorities are subject 
to change at any time (e.g., newly identified safety issues). The 
Agency is not required to publish every guidance on either list if the 
resources needed would be to the detriment of meeting quantitative 
review timelines and statutory obligations. In addition, the Agency is 
not precluded from issuing guidance documents that are not on either 
list.
    Stakeholder feedback on guidance priorities is important to ensure 
that the CDRH guidance program meets the needs of stakeholders. The 
feedback received on the FY 2017 list was mostly in agreement, and CDRH 
continued to work toward issuing the guidances on this list. In FY 
2017, CDRH issued 9 of 27 guidances on the FY 2017 list (6 from the A-
list, 3 from the B-list). At this time, CDRH has decided not to pursue 
several guidances that were on the FY 2017 A or B list, due to factors 
including feedback from industry.


[[Page 58431]]


    Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26721 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P