82 FR 43390 - Utilizing Animal Studies To Evaluate Organ Preservation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 178 (September 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 178 (September 15, 2017)
| Page Range | 43390-43391 | |
| FR Document | 2017-19613 |
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)] [Notices] [Pages 43390-43391] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19613] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-4886] Utilizing Animal Studies To Evaluate Organ Preservation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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-2017-D-4886 for ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1504, Silver Spring, MD 20993-0002, 301- 796-6439. SUPPLEMENTARY INFORMATION: [[Page 43391]] I. Background FDA is announcing the availability of a draft leapfrog guidance for industry and FDA staff entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices, with careful considerations of regulatory least burdensome principles, as well as, ethical principles in animal testing. This draft guidance provides clarity on premarket recommendations to develop animal transplant models for organ preservation technologies, which will streamline initiation of clinical studies. Optimizing animal and clinical study designs for premarket submissions will allow us to bring novel organ preservation devices to the market faster to increase the availability of organs for transplant for patients awaiting transplants. Early stakeholder feedback was sought to inform the development of this draft guidance through CDRH's notice on the fiscal year 2016 proposed guidance development issued December 29, 2015 (80 FR 81335), available at https://www.federalregister.gov/documents/2015/12/29/2015-32726/medical-device-user-fee-and-modernization-act-notice-to-public-of-web-site-location-of-fiscal-year#h-14. Specific questions were posed to solicit input into the context of the guidance and comments were collected through Docket No. FDA-2012-N-1021. This draft guidance is a leapfrog guidance; leapfrog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding the content of premarket submissions for emerging technologies and new clinical applications that are likely to be of public health importance very early in product development. This leapfrog draft guidance represents the Agency's initial thinking, and our recommendations may change as more information becomes available. The Agency strongly encourages manufacturers to engage with CDRH through the Pre-Submission process to obtain more detailed feedback regarding their organ preservation device. For more information on Pre- Submissions, please see ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' at (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf). II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Utilizing Animal Studies to Evaluate Organ Preservation Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500083 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance document refers to previously approved collections of information found in FDA regulations and guidances. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 58 regarding good laboratory practices have been approved under OMB control number 0910-0119. The collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485. The collections of information in 21 CFR part 807, subpart E regarding premarket notification have been approved under OMB control number 0910-0120. The collections of information in 21 CFR part 812 regarding investigational device exemptions have been approved under OMB control number 0910-0078. The collections of information in 21 CFR part 814, subparts A through E regarding premarket approval have been approved under OMB control number 0910-0231. The collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332. The collections of information in 21 CFR part 820 regarding the Quality System regulation have been approved under OMB control number 0910-0073. The collections of information in the guidance document entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: September 6, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19613 Filed 9-14-17; 8:45 am] BILLING CODE 4164-01-P
![43390 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
FDA has reviewed its records and, ADDRESSES: You may submit comments information you claim to be confidential
under § 314.161, has determined that on any guidance at any time as follows: with a heading or cover note that states
the drug products listed were not ‘‘THIS DOCUMENT CONTAINS
Electronic Submissions
withdrawn from sale for reasons of CONFIDENTIAL INFORMATION.’’ The
safety or effectiveness. Accordingly, the Submit electronic comments in the Agency will review this copy, including
Agency will continue to list the drug following way: the claimed confidential information, in
products in the ‘‘Discontinued Drug • Federal eRulemaking Portal: its consideration of comments. The
Product List’’ section of the Orange https://www.regulations.gov. Follow the second copy, which will have the
Book. The ‘‘Discontinued Drug Product instructions for submitting comments. claimed confidential information
List’’ identifies, among other items, drug Comments submitted electronically, redacted/blacked out, will be available
products that have been discontinued including attachments, to https:// for public viewing and posted on
from marketing for reasons other than www.regulations.gov will be posted to https://www.regulations.gov. Submit
safety or effectiveness. the docket unchanged. Because your both copies to the Dockets Management
Approved ANDAs that refer to the comment will be made public, you are Staff. If you do not wish your name and
NDAs and ANDAs listed are unaffected solely responsible for ensuring that your contact information to be made publicly
by the discontinued marketing of the comment does not include any available, you can provide this
products subject to those NDAs and confidential information that you or a information on the cover sheet and not
ANDAs. Additional ANDAs that refer to third party may not wish to be posted, in the body of your comments and you
these products may also be approved by such as medical information, your or must identify this information as
the Agency if they comply with relevant anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
legal and regulatory requirements. If confidential business information, such as ‘‘confidential’’ will not be disclosed
FDA determines that labeling for these as a manufacturing process. Please note except in accordance with 21 CFR 10.20
drug products should be revised to meet that if you include your name, contact and other applicable disclosure law. For
current standards, the Agency will information, or other information that more information about FDA’s posting
advise ANDA applicants to submit such identifies you in the body of your of comments to public dockets, see 80
labeling. comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Dated: September 11, 2017. • If you want to submit a comment
Anna K. Abram,
fdsys/pkg/FR-2015-09-18/pdf/2015-
with confidential information that you 23389.pdf.
Deputy Commissioner for Policy, Planning, do not wish to be made available to the
Legislation, and Analysis. Docket: For access to the docket to
public, submit the comment as a
read background documents or the
[FR Doc. 2017–19611 Filed 9–14–17; 8:45 am] written/paper submission and in the
electronic and written/paper comments
BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper
received, go to https://
Submissions’’ and ‘‘Instructions’’).
www.regulations.gov and insert the
DEPARTMENT OF HEALTH AND Written/Paper Submissions docket number, found in brackets in the
HUMAN SERVICES Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
Food and Drug Administration • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
[Docket No. FDA–2017–D–4886] Management Staff (HFA–305), Food and Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any
Utilizing Animal Studies To Evaluate Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
Organ Preservation Devices; Draft • For written/paper comments 10.115(g)(5)). An electronic copy of the
Guidance for Industry and Food and submitted to the Dockets Management guidance document is available for
Drug Administration Staff; Availability Staff, FDA will post your comment, as download from the internet. See the
well as any attachments, except for SUPPLEMENTARY INFORMATION section for
AGENCY: Food and Drug Administration, information submitted, marked and information on electronic access to the
HHS. identified, as confidential, if submitted guidance. Submit written requests for a
ACTION: Notice of availability. as detailed in ‘‘Instructions.’’ single hard copy of the draft guidance
Instructions: All submissions received document entitled ‘‘Utilizing Animal
SUMMARY: The Food and Drug must include the Docket No. FDA– Studies to Evaluate Organ Preservation
Administration (FDA or Agency) is 2017–D–4886 for ‘‘Utilizing Animal Devices’’ to the Office of the Center
announcing the availability of the draft Studies to Evaluate Organ Preservation Director, Guidance and Policy
guidance entitled ‘‘Utilizing Animal Devices.’’ Received comments will be Development, Center for Devices and
Studies to Evaluate Organ Preservation placed in the docket and, except for Radiological Health, Food and Drug
Devices.’’ The intent of this draft those submitted as ‘‘Confidential Administration, 10903 New Hampshire
guidance is to provide Submissions,’’ publicly viewable at Ave., Bldg. 66, Rm. 5431, Silver Spring,
recommendations regarding best https://www.regulations.gov or at the MD 20993–0002. Send one self-
practices for utilizing animal studies for Dockets Management Staff between 9 addressed adhesive label to assist that
the evaluation of organ preservation a.m. and 4 p.m., Monday through office in processing your request.
devices. This draft guidance is not final Friday.
mstockstill on DSK30JT082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
nor is it in effect at this time. • Confidential Submissions—To
DATES: Submit either electronic or submit a comment with confidential Elizabeth Kunkoski, Center for Devices
written comments on the draft guidance information that you do not wish to be and Radiological Health, Food and Drug
by November 14, 2017 to ensure that the made publicly available, submit your Administration, 10903 New Hampshire
Agency considers your comment on this comments only as a written/paper Ave., Bldg. 66, Rm. 1504, Silver Spring,
draft guidance before it begins work on submission. You should submit two MD 20993–0002, 301–796–6439.
the final version of the guidance. copies total. One copy will include the SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43391
I. Background II. Significance of Guidance approved under OMB control number
FDA is announcing the availability of This draft guidance is being issued 0910–0332. The collections of
a draft leapfrog guidance for industry consistent with FDA’s good guidance information in 21 CFR part 820
and FDA staff entitled ‘‘Utilizing practices regulation (21 CFR 10.115). regarding the Quality System regulation
Animal Studies to Evaluate Organ The draft guidance, when finalized, will have been approved under OMB control
Preservation Devices.’’ The intent of this number 0910–0073. The collections of
represent the current thinking of FDA
draft guidance is to provide information in the guidance document
on ‘‘Utilizing Animal Studies to
recommendations regarding best entitled ‘‘Requests for Feedback on
Evaluate Organ Preservation Devices.’’ It
practices for utilizing animal studies for Medical Device Submissions: The Pre-
does not establish any rights for any
the evaluation of organ preservation Submission Program and Meetings with
person and is not binding on FDA or the
devices, with careful considerations of Food and Drug Administration Staff’’
public. You can use an alternative
regulatory least burdensome principles, have been approved under OMB control
approach if it satisfies the requirements
as well as, ethical principles in animal number 0910–0756.
of the applicable statutes and
testing. This draft guidance provides regulations. This guidance is not subject Dated: September 6, 2017.
clarity on premarket recommendations to Executive Order 12866. Anna K. Abram,
to develop animal transplant models for Deputy Commissioner for Policy, Planning,
organ preservation technologies, which III. Electronic Access Legislation, and Analysis.
will streamline initiation of clinical Persons interested in obtaining a copy [FR Doc. 2017–19613 Filed 9–14–17; 8:45 am]
studies. Optimizing animal and clinical of the draft guidance may do so by BILLING CODE 4164–01–P
study designs for premarket downloading an electronic copy from
submissions will allow us to bring novel the internet. A search capability for all
organ preservation devices to the market Center for Devices and Radiological DEPARTMENT OF HEALTH AND
faster to increase the availability of Health guidance documents is available HUMAN SERVICES
organs for transplant for patients at https://www.fda.gov/MedicalDevices/
awaiting transplants. Early stakeholder DeviceRegulationandGuidance/ Health Resources and Services
feedback was sought to inform the GuidanceDocuments/default.htm. This Administration
development of this draft guidance guidance document is also available at Agency Information Collection
through CDRH’s notice on the fiscal year https://www.regulations.gov. Persons Activities: Submission to OMB for
2016 proposed guidance development unable to download an electronic copy Review and Approval; Public Comment
issued December 29, 2015 (80 FR of ‘‘Utilizing Animal Studies to Evaluate Request; Information Collection
81335), available at https:// Organ Preservation Devices’’ may send Request Title: Poison Help General
www.federalregister.gov/documents/ an email request to CDRH-Guidance@ Population Survey, OMB No. 0915–
2015/12/29/2015-32726/medical-device- fda.hhs.gov to receive an electronic 0343, Reinstatement
user-fee-and-modernization-act-notice- copy of the document. Please use the
to-public-of-web-site-location-of-fiscal- document number 1500083 to identify AGENCY: Health Resources and Services
year#h-14. Specific questions were the guidance you are requesting. Administration (HRSA), Department of
posed to solicit input into the context of Health and Human Services (HHS).
IV. Paperwork Reduction Act of 1995
the guidance and comments were ACTION: Notice.
collected through Docket No. FDA– This draft guidance document refers
2012–N–1021. to previously approved collections of SUMMARY: In compliance with the
This draft guidance is a leapfrog information found in FDA regulations Paperwork Reduction Act of 1995,
guidance; leapfrog guidances are and guidances. These collections of HRSA has submitted an Information
intended to serve as a mechanism by information are subject to review by the Collection Request (ICR) to the Office of
which the Agency can share initial Office of Management and Budget Management and Budget (OMB) for
thoughts regarding the content of (OMB) under the Paperwork Reduction review and approval. Comments
premarket submissions for emerging Act of 1995 (44 U.S.C. 3501–3520). The submitted during the first public review
technologies and new clinical collections of information in 21 CFR of this ICR will be provided to OMB.
applications that are likely to be of part 58 regarding good laboratory The ICR is for reinstatement with
public health importance very early in practices have been approved under change of a previously approved
product development. This leapfrog OMB control number 0910–0119. The information collection assigned OMB
draft guidance represents the Agency’s collections of information in 21 CFR control number 0915–0343 that expired
initial thinking, and our part 801 regarding labeling have been on May 31, 2014. OMB will accept
recommendations may change as more approved under OMB control number further comments from the public
information becomes available. The 0910–0485. The collections of during the review and approval period.
Agency strongly encourages information in 21 CFR part 807, subpart DATES: Comments on this ICR should be
manufacturers to engage with CDRH E regarding premarket notification have received no later than October 16, 2017.
through the Pre-Submission process to been approved under OMB control ADDRESSES: Submit your comments,
obtain more detailed feedback regarding number 0910–0120. The collections of including the ICR Title, to the desk
their organ preservation device. For information in 21 CFR part 812 officer for HRSA, either by email to
more information on Pre-Submissions, regarding investigational device OIRA_submission@omb.eop.gov or by
please see ‘‘Requests for Feedback on exemptions have been approved under fax to 202–395–5806.
mstockstill on DSK30JT082PROD with NOTICES
Medical Device Submissions: The Pre- OMB control number 0910–0078. The FOR FURTHER INFORMATION CONTACT: To
Submission Program and Meetings with collections of information in 21 CFR request a copy of the clearance requests
Food and Drug Administration Staff’’ at part 814, subparts A through E regarding submitted to OMB for review, email the
(https://www.fda.gov/downloads/ premarket approval have been approved HRSA Information Collection Clearance
MedicalDevices/ under OMB control number 0910–0231. Officer, Lisa Wright-Solomon, at
DeviceRegulationandGuidance/ The collections of information in 21 paperwork@hrsa.gov or call (301) 443–
GuidanceDocuments/UCM311176.pdf). CFR part 814, subpart H have been 1984.
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Document Created: 2017-09-15 00:18:24
Document Modified: 2017-09-15 00:18:24
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Elizabeth Kunkoski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1504, Silver Spring, MD 20993-0002, 301- 796-6439. | |
| FR Citation | 82 FR 43390 |
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