82 FR 58429 - Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 237 (December 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 237 (December 12, 2017)
| Page Range | 58429-58431 | |
| FR Document | 2017-26721 |
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)] [Notices] [Pages 58429-58431] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26721] [[Page 58429]] ----------------------------------------------------------------------- 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.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 (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
![Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58429
DEPARTMENT OF HEALTH AND written/paper submission and in the Docket: For access to the docket to
HUMAN SERVICES manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Food and Drug Administration received, go to https://
Written/Paper Submissions
[Docket No. FDA–2012–N–1021] www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Notice to Public of Website Location of follows: heading of this document, into the
Center for Devices and Radiological • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
Health Fiscal Year 2018 Proposed written/paper submissions): Dockets and/or go to the Dockets Management
Guidance Development Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers Rockville, MD 20852.
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
HHS.
• For written/paper comments Erica Takai, Center for Devices and
ACTION: Notice. submitted to the Dockets Management Radiological Health, Food and Drug
SUMMARY: The Food and Drug Staff, FDA will post your comment, as Administration, 10903 New Hampshire
Administration (FDA or the Agency) is well as any attachments, except for Ave., Bldg. 66, Rm. 5456, Silver Spring,
announcing the website location where information submitted, marked and MD 20993–0002, 301–796–6353.
the Agency will post two lists of identified, as confidential, if submitted SUPPLEMENTARY INFORMATION:
guidance documents that CDRH (or the as detailed in ‘‘Instructions.’’
Instructions: All submissions received I. Background
Center) intends to publish in fiscal year
(FY) 2018. In addition, FDA has must include the Docket No. FDA– During negotiations on the Medical
established a docket where interested 2012–N–1021 for ‘‘Notice to Public of Device User Fee Amendments of 2012
persons may comment on the priority of Website Location of CDRH Fiscal Year (MDUFA III), Title II, Food and Drug
topics for guidance, provide comments 2018 Proposed Guidance Development.’’ Administration Safety and Innovation
and/or propose draft language for those Received comments will be placed in Act (Pub. L. 112–114), FDA agreed to
topics, suggest topics for new or the docket and, except for those meet a variety of quantitative and
different guidance documents, comment submitted as ‘‘Confidential qualitative goals intended to help get
on the applicability of guidance Submissions,’’ publicly viewable at safe and effective medical devices to
documents that have issued previously, https://www.regulations.gov or at the market more quickly. Among these
and provide any other comments that Dockets Management Staff between 9 commitments included:
could benefit the CDRH guidance a.m. and 4 p.m., Monday through • Annually posting a list of priority
program and its engagement with Friday. medical device guidance documents
stakeholders. This feedback is critical to • Confidential Submissions—To that the Agency intends to publish
the CDRH guidance program to ensure submit a comment with confidential within 12 months of the date this list is
that we meet stakeholder needs. information that you do not wish to be published each fiscal year (the ‘‘A-list’’),
DATES: Submit either electronic or made publicly available, submit your and
written comments by February 12, 2018. comments only as a written/paper • Annually posting a list of device
ADDRESSES: You may submit comments submission. You should submit two guidance documents that the Agency
as follows: copies total. One copy will include the intends to publish, as the Agency’s
information you claim to be confidential guidance-development resources permit
Electronic Submissions with a heading or cover note that states each fiscal year (the ‘‘B-list’’).
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS The Medical Device User Fee
following way: CONFIDENTIAL INFORMATION.’’ The Amendments of 2017 (MDUFA IV), FDA
• Federal eRulemaking Portal: Agency will review this copy, including Reauthorization Act of 2017 (Pub. L.
https://www.regulations.gov. Follow the the claimed confidential information, in 115–52) maintained these commitments.
instructions for submitting comments. its consideration of comments. The FDA welcomes comments on any or
Comments submitted electronically, second copy, which will have the all of the guidance documents on the
including attachments, to https:// claimed confidential information lists as explained in 21 CFR 10.115(f)(5).
www.regulations.gov will be posted to redacted/blacked out, will be available FDA has established Docket No. FDA–
the docket unchanged. Because your for public viewing and posted on 2012–N–1021 where comments on the
comment will be made public, you are https://www.regulations.gov. Submit FY 2018 lists, draft language for
solely responsible for ensuring that your both copies to the Dockets Management guidance documents on those topics,
comment does not include any Staff. If you do not wish your name and suggestions for new or different
confidential information that you or a contact information to be made publicly guidances, and relative priority of
third party may not wish to be posted, available, you can provide this guidance documents may be submitted
such as medical information, your or information on the cover sheet and not and shared with the public (see
anyone else’s Social Security number, or in the body of your comments and you ADDRESSES). FDA believes this docket is
confidential business information, such must identify this information as a valuable tool for receiving information
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked from interested persons and will update
that if you include your name, contact as ‘‘confidential’’ will not be disclosed these lists after considering public
information, or other information that except in accordance with 21 CFR 10.20 comments, where appropriate. FDA
ethrower on DSK3G9T082PROD with NOTICES
identifies you in the body of your and other applicable disclosure law. For anticipates that feedback from interested
comments, that information will be more information about FDA’s posting persons will allow CDRH to better
posted on https://www.regulations.gov. of comments to public dockets, see 80 prioritize and more efficiently draft
• If you want to submit a comment FR 56469, September 18, 2015, or access guidances to meet the needs of the
with confidential information that you the information at: https://www.gpo.gov/ Agency and our stakeholders.
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- In addition to posting the lists of
public, submit the comment as a 23389.pdf. prioritized device guidance documents,
VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/82_FR_58666/page/1.svg)
![Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58431
Dated: December 7, 2017. Secretary, Department of Health and Advisory Council, in consultation with
Leslie Kux, Human Services. the Secretaries of Defense and
Associate Commissioner for Policy. ACTION: Notice. Agriculture. Activities of the Advisory
[FR Doc. 2017–26721 Filed 12–11–17; 8:45 am] Council are governed by the provisions
SUMMARY: As stipulated by the Federal of Public Law 92–463, as amended (5
BILLING CODE 4164–01–P
Advisory Committee Act, the U.S.C. App.), which sets forth standards
Department of Health and Human for the formation and use of federal
DEPARTMENT OF HEALTH AND Services (HHS) is hereby giving notice advisory committees.
HUMAN SERVICES that a meeting is scheduled to be held The Advisory Council will provide
on January 24, 2018, of the Presidential advice, information, and
Meeting of the Chronic Fatigue Advisory Council on Combating recommendations to the Secretary of
Syndrome Advisory Committee; Antibiotic-Resistant Bacteria (Advisory HHS regarding programs and policies
Amendment Council). The meeting will be open to intended to support and evaluate the
the public; a public comment session implementation of Executive Order
AGENCY: Office of the Assistant will be held during the meeting. Pre- 13676, including the National Strategy
Secretary for Health, Office of the registration is required for members of for Combating Antibiotic-Resistant
Secretary, Department of Health and the public who wish to attend the Bacteria and the National Action Plan
Human Services. meeting and who wish to participate in for Combating Antibiotic-Resistant
ACTION: Notice; amendment. the public comment session. Individuals Bacteria. The Advisory Council shall
who wish to attend the meeting and/or function solely for advisory purposes.
SUMMARY: A notice was published in the send in their public comment via email In carrying out its mission, the
Federal Register on November 27, 2017, should send an email to CARB@hhs.gov. Advisory Council will provide advice,
announcing an in-person meeting of the Registration information is available on information, and recommendations to
Chronic Fatigue Syndrome Advisory the website http://www.hhs.gov/ash/ the Secretary regarding programs and
Committee (CFSAC) on Wednesday, carb/ and must be completed by January policies intended to preserve the
December 13, 2017, from 9:00 a.m. until 15, 2018; all in-person attendees must effectiveness of antibiotics by
3:30 p.m. and Thursday, December 14, pre-register by this date. Additional optimizing their use; advance research
2017, from 9:00 a.m. until 5:00 p.m. The information about registering for the to develop improved methods for
meeting will be held at the U.S. meeting and providing public comment combating antibiotic resistance and
Department of Health and Human can be obtained at http://www.hhs.gov/ conducting antibiotic stewardship;
Services, Hubert H. Humphrey Building, ash/carb/ on the Meetings page. strengthen surveillance of antibiotic-
Room 800, 200 Independence Avenue resistant bacterial infections; prevent
DATES: The meeting is scheduled to be
SW, Washington, DC 20201. The notice the transmission of antibiotic-resistant
is being amended to provide security held on January 24, 2018, from 9:00 a.m.
to 5:00 p.m. ET (times are tentative and bacterial infections; advance the
procedures to enter the Hubert H. development of rapid point-of-care and
Humphrey Building. Individuals subject to change). The confirmed times
and agenda items for the meeting will be agricultural diagnostics; further research
interested in attending the meeting in on new treatments for bacterial
person need to show a state or federal posted on the website for the Advisory
Council at http://www.hhs.gov/ash/ infections; develop alternatives to
government issued I.D. with a antibiotics for agricultural purposes;
photograph. Individuals can also email carb/ when this information becomes
available. Pre-registration for attending maximize the dissemination of up-to-
the CFSAC inbox (cfsac@hhs.gov) in date information on the appropriate and
order to have their names added to a list the meeting in person is required to be
completed no later than January 15, proper use of antibiotics to the general
of attendees. However, it is still public and human and animal
necessary for individuals to present a 2018; public attendance at the meeting
healthcare providers; and improve
photo I.D. to gain entrance to Hubert H. is limited to the available space.
international coordination of efforts to
Humphrey Building. All participants ADDRESSES: U.S. Department of Health
combat antibiotic resistance.
will be escorted to the meeting room. and Human Services, Hubert H. The public meeting will be dedicated
Space is limited. Humphrey Building, Great Hall, 200 to two main activities. The Advisory
Independence Avenue SW, Washington, Council will deliberate and vote on a
FOR FURTHER INFORMATION CONTACT: CDR
DC 20201. letter drafted by the Immediate Action
Gustavo Ceinos, 202–690–7650; Email The meeting can also be accessed
address: cfsac@hhs.gov. Subcommittee. The remainder of the
through a live webcast on the day of the day will be focused on the topic of
Dated: December 6, 2017. meeting. For more information, visit antibiotic stewardship in food and
Gustavo Ceinos, http://www.hhs.gov/ash/carb/. companion animals. The meeting
CDR, USPHS, Designated Federal Officer, FOR FURTHER INFORMATION CONTACT: agenda will be posted on the Advisory
Chronic Fatigue Syndrome Advisory Jomana Musmar, Acting Designated Council website at http://www.hhs.gov/
Committee. Federal Officer, Presidential Advisory ash/carb/ when it has been finalized.
[FR Doc. 2017–26739 Filed 12–11–17; 8:45 am] Council on Combating Antibiotic- All agenda items are tentative and
BILLING CODE 4150–42–P Resistant Bacteria, Office of the subject to change.
Assistant Secretary for Health, U.S. Public attendance at the meeting is
Department of Health and Human limited to the available space.
DEPARTMENT OF HEALTH AND Services, Hubert H. Humphrey Building, Individuals who plan to attend and
ethrower on DSK3G9T082PROD with NOTICES
HUMAN SERVICES 200 Independence Avenue SW, Room need special assistance, such as sign
715H, Washington, DC 20201. Phone: language interpretation or other
Meeting of the Presidential Advisory (202) 690–5566; email: CARB@hhs.gov.
Council on Combating Antibiotic- reasonable accommodations, should
Resistant Bacteria SUPPLEMENTARY INFORMATION: Under notify the Advisory Council at the
Executive Order 13676, dated address/telephone number listed above
AGENCY: Office of the Assistant September 18, 2014, authority was given at least one week prior to the meeting.
Secretary for Health, Office of the to the Secretary of HHS to establish the For those unable to attend in person, a
VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/82_FR_58666/page/3.svg)
Document Created: 2018-10-25 10:49:03
Document Modified: 2018-10-25 10:49:03
| 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 12, 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 | 82 FR 58429 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR