81 FR 94382 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 247 (December 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 247 (December 23, 2016)
| Page Range | 94382-94384 | |
| FR Document | 2016-31006 |
[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)] [Notices] [Pages 94382-94384] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31006] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1021] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the Web site 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) 2017. 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 21, 2017. 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 [[Page 94383]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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 ``Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 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''). 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 2017 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, FDA has committed to updating its Web site 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 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 another 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. In FY 2016, CDRH finalized 2 and withdrew 5 of 12 draft guidances issued prior to October 1, 2010, and has been continuing to work towards finalizing the remaining draft guidances. Looking forward, in FY 2017, CDRH will strive to finalize, withdraw, or re-open the comment period for 50 percent of existing draft guidances issued prior to October 1, 2011. CDRH expects to renew or modify, as appropriate, these performance goals in FY 2017 and subsequent years. [[Page 94384]] 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 has included these guidances topics on the FY 2017 B-List as we progress toward issuance of draft policies reflecting early stakeholder input as appropriate. We also welcome 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 500 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 Web site where CDRH has posted the ``A-list'' and ``B-list'' for FY 2017, CDRH has also posted a list of final guidance documents that issued in 2007, 1997, 1987, and 1977.\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 2018, CDRH expects to provide a list of the final guidance documents that issued in 2008, 1998, 1988, and 1978; the annual notice for FY 2019 is expected to provide a list of the final guidance documents that issued in 2009, 1999, 1989, and 1979, 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 2016, CDRH received comments regarding guidances issued in 2006, 1996, and 1986, and has withdrawn 12 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 on this retrospective review list was revised, and revision of several guidance documents is also being considered as resources permit. Consistent with 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 Web site, feedback on any guidance is appreciated and will be considered. III. Web Site Location of Guidance Lists This notice announces the Web site location of the document that provides the A and B lists of guidance documents, which CDRH is intending to publish during FY 2017. To access these two lists, visit FDA's Web site at http://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). Topics on this and past guidance priority lists may be removed or modified based on current priorities. 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 2016 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2016, CDRH issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). In addition, for the guidances that were on the FY 2016 A or B list but could not be published within FY 2016, and for which we received feedback that these guidances were of high priority, CDRH has recommitted to publish these guidances by placing them on the annual agenda for FY 2017, as appropriate. Dated: December 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31006 Filed 12-22-16; 8:45 am] BILLING CODE 4164-01-P
![94382 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
1996), as well as the William DEPARTMENT OF HEALTH AND with linkages to their databases that
Wilberforce Trafficking Victims HUMAN SERVICES store consumer education information.
Protection Reauthorization Act of 2008 The Childcare.gov Web site, maintained
(Pub. L. 110–457), which authorizes Administration for Children and by Office of Child care will collect child
post release services under certain Families care specific information from State and
conditions to eligible children. All Territory databases and make that
Proposed Information Collection information available for parents using
programs must comply with the Flores
Activity; Comment Request the childcare.gov Web site to search for
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996), pertinent Proposed Projects: Childcare.gov. child care that meets their needs.
regulations and ORR policies and Title: CCDF Grantee Consumer Childcare.gov will provide consumers,
procedures. Education Database Linkages with directly or through linkages to State and
Childcare.gov. Territory data sources, with the
Christopher Beach, OMB No.: New. following minimum information and
Office of Administration, Office of Financial Description: The Child Care and services:
Services, Division of Grants Policy. Development Block Grant (CCDBG) Act (1) A localized list of all eligible child
[FR Doc. 2016–31014 Filed 12–22–16; 8:45 am] of 2014 requires HHS to create a care providers, differentiating between
BILLING CODE 4184–45–P
national Web site for consumer licensed and license-exempt providers;
education. The National Web site will (2) Child care provider-specific
be hosted at childcare.gov. CCDBG information from a quality rating and
grantees are also required to stand up improvement system or information
child care consumer education Web about other quality indicators, to the
sites that meet the requirements of the extent that such information is publicly
law. The CCDBG Final Rule aligns the available and practicable.
National and State Web sites by Respondents: CCDBG grantees in
requiring Lead Agencies to provide HHS States and Territories.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Childcare.gov data collection: Establish and maintain Web-based data con-
nection in subsequent years ........................................................................ 56 260 .57 8,299
Estimated Total Annual Burden respondents, including through the use or the Center) intends to publish in
Hours: 8,299 hours. of automated collection techniques or fiscal year (FY) 2017. In addition, FDA
In compliance with the requirements other forms of information technology. has established a docket where
of the Paperwork Reduction Act of 1995 Consideration will be given to interested persons may comment on the
(Pub. L. 104–13, 44 U.S.C. Chap 35), the comments and suggestions submitted priority of topics for guidance, provide
Administration for Children and within 60 days of this publication. comments and/or propose draft
Families is soliciting public comment language for those topics, suggest topics
Robert Sargis,
on the specific aspects of the for new or different guidance
information collection described above. Reports Clearance Officer. documents, comment on the
Copies of the proposed collection of [FR Doc. 2016–30982 Filed 12–22–16; 8:45 am] applicability of guidance documents
information can be obtained and BILLING CODE 4184–01–P that have issued previously, and
comments may be forwarded by writing provide any other comments that could
to the Administration for Children and benefit the CDRH guidance program and
Families, Office of Planning, Research DEPARTMENT OF HEALTH AND its engagement with stakeholders. This
and Evaluation, 330 C Street SW., HUMAN SERVICES feedback is critical to the CDRH
Washington, DC 20201. Attn: ACF Food and Drug Administration guidance program to ensure that we
Reports Clearance Officer. Email meet stakeholder needs.
address: infocollection@acf.hhs.gov. All [Docket No. FDA–2012–N–1021] DATES: Submit either electronic or
requests should be identified by the title written comments by February 21, 2017.
of the information collection. Medical Device User Fee and
ADDRESSES: You may submit comments
The Department specifically requests Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2017 as follows:
comments on: (a) Whether the proposed
collection of information is necessary Proposed Guidance Development Electronic Submissions
for the proper performance of the AGENCY: Food and Drug Administration, Submit electronic comments in the
functions of the agency, including HHS. following way:
whether the information shall have • Federal eRulemaking Portal: https://
mstockstill on DSK3G9T082PROD with NOTICES
ACTION: Notice.
practical utility; (b) the accuracy of the www.regulations.gov. Follow the
agency’s estimate of the burden of the SUMMARY: The Food and Drug instructions for submitting comments.
proposed collection of information; (c) Administration (FDA or the Agency) is Comments submitted electronically,
the quality, utility, and clarity of the announcing the Web site location where including attachments, to https://
information to be collected; and (d) the Agency will post two lists of www.regulations.gov will be posted to
ways to minimize the burden of the guidance documents that the Center for the docket unchanged. Because your
collection of information on Devices and Radiological Health (CDRH comment will be made public, you are
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![94384 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
B. Earlier Stakeholder Involvement in annually through FY 2025 so that by review timelines and statutory
Guidance Development 2025, FDA and stakeholders will have obligations. In addition, the Agency is
CDRH has received feedback that assessed the applicability of all not precluded from issuing guidance
stakeholders desire earlier involvement guidances older than 10 years. For documents that are not on either list.
in the guidance process and has taken instance, in the annual notice for FY Stakeholder feedback on guidance
steps to create a mechanism to address 2018, CDRH expects to provide a list of priorities is important to ensure that the
this request. In FY 2016, in anticipation the final guidance documents that CDRH guidance program meets the
of guidance documents expected to be issued in 2008, 1998, 1988, and 1978; needs of stakeholders. The feedback
developed, CDRH sought stakeholder the annual notice for FY 2019 is received on the FY 2016 list was mostly
input regarding electromagnetic expected to provide a list of the final in agreement, and CDRH continued to
compatibility of electrically powered guidance documents that issued in work toward issuing the guidances on
medical devices and regarding utilizing 2009, 1999, 1989, and 1979, and so on. this list. In FY 2016, CDRH issued 20 of
animal studies to evaluate the safety of CDRH will consider the comments 33 guidances on the FY 2016 list (14
organ preservation devices and received from this retrospective review from the A-list, 6 from the B-list). In
solutions. FDA appreciated the feedback when determining priorities for addition, for the guidances that were on
received and considered it in the updating guidance documents and will the FY 2016 A or B list but could not
development of these guidances. revise these as resources permit. be published within FY 2016, and for
Demonstrating commitment to In FY 2016, CDRH received comments which we received feedback that these
incorporating stakeholder input, CDRH regarding guidances issued in 2006, guidances were of high priority, CDRH
has included these guidances topics on 1996, and 1986, and has withdrawn 12 has recommitted to publish these
the FY 2017 B-List as we progress guidance documents in response to guidances by placing them on the
toward issuance of draft policies comments received and because these annual agenda for FY 2017, as
reflecting early stakeholder input as guidance documents were determined appropriate.
appropriate. to no longer represent the Agency’s
current thinking. One guidance on this Dated: December 19, 2016.
We also welcome any additional Leslie Kux,
feedback for improving the guidance retrospective review list was revised,
and revision of several guidance Associate Commissioner for Policy.
program and the quality of CDRH
guidance documents. documents is also being considered as [FR Doc. 2016–31006 Filed 12–22–16; 8:45 am]
resources permit. BILLING CODE 4164–01–P
C. Applicability of Previously Issued Consistent with Good Guidance
Final Guidance Practices regulation at 21 CFR
CDRH has issued over 500 final 10.115(f)(4), CDRH would appreciate DEPARTMENT OF HEALTH AND
guidance documents to provide suggestions that CDRH revise or HUMAN SERVICES
stakeholders with the Agency’s thinking withdraw an already existing guidance
on numerous topics. Each guidance document. We request that the Food and Drug Administration
reflected the Agency’s current position suggestion clearly explain why the
at the time that it was issued. However, guidance document should be revised or [Docket No. FDA–2016–N–4342]
the guidance program has issued these withdrawn and, if applicable, how it
guidances over a period of 30 years, should be revised. While we are Agency Information Collection
raising the question of how current requesting feedback on the list of Activities; Proposed Collection;
previously issued final guidances previously issued final guidances Comment Request; Application for
remain. CDRH has resolved to address located in the annual agenda Web site, Participation in the Food and Drug
this concern through a staged review of feedback on any guidance is appreciated Administration Regulatory Science
previously issued final guidances in and will be considered. Student Internship Program
collaboration with stakeholders. At the III. Web Site Location of Guidance Lists AGENCY: Food and Drug Administration,
Web site where CDRH has posted the HHS.
‘‘A-list’’ and ‘‘B-list’’ for FY 2017, CDRH This notice announces the Web site
location of the document that provides ACTION: Notice.
has also posted a list of final guidance
documents that issued in 2007, 1997, the A and B lists of guidance
documents, which CDRH is intending to SUMMARY: The Food and Drug
1987, and 1977.1 CDRH is interested in Administration (FDA) is announcing an
external feedback on whether any of publish during FY 2017. To access these
two lists, visit FDA’s Web site at http:// opportunity for public comment on the
these final guidances should be revised proposed collection of certain
or withdrawn. In addition, for guidances www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/ information by the Agency. Under the
that are recommended for revision, Paperwork Reduction Act of 1995 (the
information explaining the need for GuidanceDocuments/ucm529396.htm.
We note that the topics on this and past PRA), Federal Agencies are required to
revision, such as, the impact and risk to publish notice in the Federal Register
public health associated with not guidance priority lists may be removed
or modified based on current priorities, concerning each proposed collection of
revising the guidance, would also be information and to allow 60 days for
helpful as the Center considers potential as well as comments received regarding
these lists. Furthermore, FDA and CDRH public comment in response to the
action with respect to these guidances. notice. This notice solicits comments on
CDRH intends to provide these lists of priorities are subject to change at any
time (e.g., newly identified safety the application for participation in
mstockstill on DSK3G9T082PROD with NOTICES
previously issued final guidances FDA’s Regulatory Science Student
issues). Topics on this and past
1 The retrospective list of final guidances does not guidance priority lists may be removed Internship Program (RSIP).
include the following: (1) Documents that are not or modified based on current priorities. DATES: Submit either electronic or
guidances but were inadvertently categorized as The Agency is not required to publish written comments on the collection of
guidance such as scientific publications, advisory information by February 21, 2017.
opinions, and interagency agreements; (2)
every guidance on either list if the
guidances actively being revised by CDRH; and (3) resources needed would be to the ADDRESSES: You may submit comments
special controls documents. detriment of meeting quantitative as follows:
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Document Created: 2016-12-23 12:29:51
Document Modified: 2016-12-23 12:29:51
| 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 February 21, 2017. | |
| 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 | 81 FR 94382 |
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