83 FR 50107 - Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance Development
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 193 (October 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 193 (October 4, 2018)
| Page Range | 50107-50109 | |
| FR Document | 2018-21596 |
[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)] [Notices] [Pages 50107-50109] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21596] ----------------------------------------------------------------------- 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 2019 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 the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2019. 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 December 3, 2018. ADDRESSES: 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 December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 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-2012-N-1021 for ``Notice to Public of website Location of CDRH Fiscal Year 2019 Proposed Guidance Development.'' 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 [[Page 50108]] 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.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: 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, Title II, Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), 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 2019 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. 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, FDA has committed to updating its website in a timely manner to reflect the Agency's review of previously published guidance documents, including the withdrawal 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, withdrawal 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 reissuance 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, reopen 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 2018, CDRH withdrew two draft guidances and reopened the comment period for two draft guidances of six draft guidances issued prior to October 1, 2012, and has been continuing to work towards taking an action on the remaining draft guidances. Looking forward, in FY 2019, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2013. B. Applicability of Previously Issued Final Guidance CDRH has issued over 450 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 2019, CDRH has also posted a list of final guidance documents that issued in 2009, 1999, 1989, and 1979.\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 2020, CDRH expects to provide a list of the final guidance documents that issued in 2010, 2000, 1990, and 1980; the annual notice for FY 2021 is expected to provide a list of the final guidance documents that issued in 2011, 2001, 1991, and 1981, 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 special controls documents. --------------------------------------------------------------------------- In FY 2018, CDRH received comments regarding guidances issued in 2008, [[Page 50109]] 1998, and 1988, and has withdrawn fourteen guidance documents in response to comments received and because these guidance documents were determined to no longer represent the Agency's current thinking. One guidance has been revised and issued as a draft guidance, and 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 2019. To access these two lists, visit FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm529396.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 2018 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2018, CDRH issued sixteen of twenty guidances on the FY 2018 list (fourteen from the A-list, two from the B-list). Dated: September 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21596 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices 50107
TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS (CBER) 1
Number of Total Average
Number of
21 CFR section records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
312.52(a) Sponsor records for the transfer of obligations
to a contract research organization ................................. 75 1.40 105 2 210
312.57 Sponsor recordkeeping showing the receipt, ship-
ment, or other disposition of the investigational drug,
and any financial interests ............................................... 335 2.70 904 100 90,400
312.62(a) Investigator recordkeeping of the disposition of
drugs ................................................................................. 453 1 453 40 18,120
312.62(b) Investigator recordkeeping of case histories of
individuals ......................................................................... 453 1 453 40 18,120
312.160(a)(3) Records pertaining to the shipment of drugs
for investigational use in laboratory research animals or
in vitro tests ...................................................................... 111 1.40 155 * 0.5 78
312.160(c) Shipper records of alternative disposition of un-
used drugs ........................................................................ 111 1.40 155 * 0.5 78
Total .............................................................................. ........................ ........................ ........................ ........................ 127,006
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Because we have received an that have issued previously, and that if you include your name, contact
increased number of IND submissions provide any other comments that could information, or other information that
since the last OMB approval of the benefit the CDRH guidance program and identifies you in the body of your
information collection, we have its engagement with stakeholders. This comments, that information will be
increased our estimate of the associated feedback is critical to the CDRH posted on https://www.regulations.gov.
burden accordingly. guidance program to ensure that we • If you want to submit a comment
Dated: September 28, 2018. meet stakeholder needs. with confidential information that you
DATES: Submit either electronic or do not wish to be made available to the
Leslie Kux,
written comments by December 3, 2018. public, submit the comment as a
Associate Commissioner for Policy.
written/paper submission and in the
[FR Doc. 2018–21610 Filed 10–3–18; 8:45 am] ADDRESSES: You may submit comments
manner detailed (see ‘‘Written/Paper
as follows. Please note that late,
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’).
untimely filed comments will not be
considered. Electronic comments must Written/Paper Submissions
DEPARTMENT OF HEALTH AND be submitted on or before December 3, Submit written/paper submissions as
HUMAN SERVICES 2018. The https://www.regulations.gov follows:
electronic filing system will accept • Mail/Hand Delivery/Courier (for
Food and Drug Administration comments until 11:59 p.m. Eastern Time written/paper submissions): Dockets
at the end of December 3, 2018. Management Staff (HFA–305), Food and
[Docket No. FDA–2012–N–1021] Comments received by mail/hand Drug Administration, 5630 Fishers
Notice to Public of Website Location of delivery/courier (for written/paper Lane, Rm. 1061, Rockville, MD 20852.
Center for Devices and Radiological submissions) will be considered timely • For written/paper comments
Health Fiscal Year 2019 Proposed if they are postmarked or the delivery submitted to the Dockets Management
Guidance Development service acceptance receipt is on or Staff, FDA will post your comment, as
before that date. well as any attachments, except for
AGENCY: Food and Drug Administration, information submitted, marked and
Electronic Submissions
HHS. identified, as confidential, if submitted
ACTION: Notice. Submit electronic comments in the as detailed in ‘‘Instructions.’’
following way: Instructions: All submissions received
SUMMARY: The Food and Drug • Federal eRulemaking Portal: must include the Docket No. FDA–
Administration (FDA or the Agency) is https://www.regulations.gov. Follow the 2012–N–1021 for ‘‘Notice to Public of
announcing the website location where instructions for submitting comments. website Location of CDRH Fiscal Year
the Agency will post two lists of Comments submitted electronically, 2019 Proposed Guidance Development.’’
guidance documents that the Center for including attachments, to https:// Received comments, those filed in a
Devices and Radiological Health (CDRH www.regulations.gov will be posted to timely manner (see ADDRESSES), will be
or the Center) intends to publish in the docket unchanged. Because your placed in the docket and, except for
fiscal year (FY) 2019. In addition, FDA comment will be made public, you are those submitted as ‘‘Confidential
has established a docket where solely responsible for ensuring that your Submissions,’’ publicly viewable at
daltland on DSKBBV9HB2PROD with NOTICES
interested persons may comment on the comment does not include any https://www.regulations.gov or at the
priority of topics for guidance, provide confidential information that you or a Dockets Management Staff between 9
comments and/or propose draft third party may not wish to be posted, a.m. and 4 p.m., Monday through
language for those topics, suggest topics such as medical information, your or Friday.
for new or different guidance anyone else’s Social Security number, or • Confidential Submissions—To
documents, comment on the confidential business information, such submit a comment with confidential
applicability of guidance documents as a manufacturing process. Please note information that you do not wish to be
VerDate Sep<11>2014 17:43 Oct 03, 2018 Jkt 247001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1](https://thefederalregister.org/doc/83_FR_50300/page/1.svg)
![Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices 50109
1998, and 1988, and has withdrawn DEPARTMENT OF HEALTH AND • If you want to submit a comment
fourteen guidance documents in HUMAN SERVICES with confidential information that you
response to comments received and do not wish to be made available to the
because these guidance documents were Food and Drug Administration public, submit the comment as a
determined to no longer represent the [Docket No. FDA–2018–D–2310] written/paper submission and in the
Agency’s current thinking. One manner detailed (see ‘‘Written/Paper
guidance has been revised and issued as Process To Request a Review of the Submissions’’ and ‘‘Instructions’’).
a draft guidance, and the revision of Food and Drug Administration’s Written/Paper Submissions
several guidance documents is also Decision Not To Issue Certain Export
being considered as resources permit. Certificates for Devices; Draft Submit written/paper submissions as
Guidance for Industry and Food and follows:
Consistent with the Good Guidance • Mail/Hand Delivery/Courier (for
Practices regulation at 21 CFR Drug Administration Staff; Availability;
Extension of Comment Period written/paper submissions): Dockets
10.115(f)(4), CDRH would appreciate Management Staff (HFA–305), Food and
suggestions that CDRH revise or AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
withdraw an already existing guidance HHS. Lane, Rm. 1061, Rockville, MD 20852.
document. We request that the • For written/paper comments
ACTION:Notice of availability; extension
suggestion clearly explain why the submitted to the Dockets Management
of comment period.
guidance document should be revised or Staff, FDA will post your comment, as
withdrawn and, if applicable, how it SUMMARY: The Food and Drug well as any attachments, except for
should be revised. While we are Administration (FDA or the Agency) is information submitted, marked and
requesting feedback on the list of extending the comment period for the identified, as confidential, if submitted
previously issued final guidances notice of availability that appeared in as detailed in ‘‘Instructions.’’
located in the annual agenda website, the Federal Register of August 17, 2018. Instructions: All submissions received
feedback on any guidance is appreciated FDA requested comments on the draft must include the Docket No. FDA–
and will be considered. guidance for industry and FDA staff 2018–D–2310 for ‘‘Process to Request a
entitled ‘‘Process To Request a Review Review of FDA’s Decision Not to Issue
III. Website Location of Guidance Lists
of FDA’s Decision Not To Issue Certain Certain Export Certificates for Devices;
This notice announces the website Export Certificates for Devices.’’ The Draft Guidance for Industry and Food
location of the document that provides Agency is taking this action in response and Drug Administration Staff.’’
the A and B lists of guidance to a request for an extension to allow Received comments will be placed in
documents, which CDRH is intending to interested persons additional time to the docket and, except for those
publish during FY 2019. To access these submit comments. submitted as ‘‘Confidential
two lists, visit FDA’s website at https:// DATES: FDA is extending the comment Submissions,’’ publicly viewable at
www.fda.gov/MedicalDevices/ period on the document published https://www.regulations.gov or at the
DeviceRegulationandGuidance/ August 17, 2018 (83 FR 41078). Submit Dockets Management Staff between 9
GuidanceDocuments/ucm529396.htm. either electronic or written comments a.m. and 4 p.m., Monday through
We note that the topics on this and past on the draft guidance by November 15, Friday.
guidance priority lists may be removed 2018, to ensure that the Agency • Confidential Submissions—To
or modified based on current priorities, considers your comment on this draft submit a comment with confidential
as well as comments received regarding guidance before it begins work on the information that you do not wish to be
these lists. Furthermore, FDA and CDRH final version of the guidance. made publicly available, submit your
priorities are subject to change at any ADDRESSES: You may submit comments comments only as a written/paper
time (e.g., newly identified safety on any guidance at any time as follows: submission. You should submit two
issues). The Agency is not required to copies total. One copy will include the
publish every guidance on either list if Electronic Submissions information you claim to be confidential
the resources needed would be to the Submit electronic comments in the with a heading or cover note that states
detriment of meeting quantitative following way: ‘‘THIS DOCUMENT CONTAINS
review timelines and statutory • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
obligations. In addition, the Agency is https://www.regulations.gov. Follow the Agency will review this copy, including
not precluded from issuing guidance instructions for submitting comments. the claimed confidential information, in
documents that are not on either list. Comments submitted electronically, its consideration of comments. The
Stakeholder feedback on guidance including attachments, to https:// second copy, which will have the
priorities is important to ensure that the www.regulations.gov will be posted to claimed confidential information
CDRH guidance program meets the the docket unchanged. Because your redacted/blacked out, will be available
needs of stakeholders. The feedback comment will be made public, you are for public viewing and posted on
received on the FY 2018 list was mostly solely responsible for ensuring that your https://www.regulations.gov. Submit
in agreement, and CDRH continued to comment does not include any both copies to the Dockets Management
work toward issuing the guidances on confidential information that you or a Staff. If you do not wish your name and
this list. In FY 2018, CDRH issued third party may not wish to be posted, contact information to be made publicly
sixteen of twenty guidances on the FY such as medical information, your or available, you can provide this
2018 list (fourteen from the A-list, two anyone else’s Social Security number, or information on the cover sheet and not
daltland on DSKBBV9HB2PROD with NOTICES
from the B-list). confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
Dated: September 28, 2018. that if you include your name, contact ‘‘confidential.’’ Any information marked
Leslie Kux, information, or other information that as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. identifies you in the body of your except in accordance with 21 CFR 10.20
[FR Doc. 2018–21596 Filed 10–3–18; 8:45 am] comments, that information will be and other applicable disclosure law. For
BILLING CODE 4164–01–P posted on https://www.regulations.gov. more information about FDA’s posting
VerDate Sep<11>2014 19:23 Oct 03, 2018 Jkt 247001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1](https://thefederalregister.org/doc/83_FR_50300/page/3.svg)
Document Created: 2018-10-04 02:02:30
Document Modified: 2018-10-04 02:02:30
| 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 | Submit either electronic or written comments by December 3, 2018. | |
| 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. | |
| FR Citation | 83 FR 50107 |
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