80 FR 61820 - General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 80, Issue 198 (October 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 198 (October 14, 2015)
| Page Range | 61820-61822 | |
| FR Document | 2015-26055 |
[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)] [Notices] [Pages 61820-61822] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26055] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3419] General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``General Considerations for Animal Studies for Medical Devices.'' FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 12, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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, [[Page 61821]] if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-D-3419 for ``General Considerations for Animal Studies for Medical Devices.'' 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 http://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 http://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. 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 ``General Considerations for Animal Studies for Medical 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: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. SUPPLEMENTARY INFORMATION: I. Background FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The animal studies utilized for the assessment of these devices typically provide initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device. The intent of this guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. We encourage sponsors to consult with us if it they wish to use a non- animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This draft guidance, when finalized, will supersede the July 2010 guidance entitled ``Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices.'' 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 General Considerations for Animal Studies for Medical 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. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``General Considerations for Animal Studies for Medical Devices,'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1802 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control numbers 0910-0231; and the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332. This draft guidance also refers to proposed collections of information described in FDA's August 14, 2014, draft guidance entitled, ``De Novo Classification Process (Evaluation of Automatic Class III Designations)'' (de novo draft guidance) (79 FR 47651). The proposed collections of information described in the de novo draft guidance are subject to review by OMB under the PRA. As required by the PRA, FDA has published an analysis of the proposed information collection described in the de novo draft guidance (79 FR 47651 at 47653) and has submitted them for OMB approval. [[Page 61822]] Dated: October 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26055 Filed 10-13-15; 8:45 am] BILLING CODE 4164-01-P
![61820 Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
OMB No.: 0970–0033 employment and other training, labor annual deliberations on refugee
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In compliance with the requirements DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
of section 506(c)(2)(A) of the Paperwork HUMAN SERVICES as follows:
Reduction Act of 1995, the Electronic Submissions
Administration for Children and Food and Drug Administration
Families is soliciting public comment Submit electronic comments in the
on the specific aspects of the [Docket No. FDA–2015–D–3419] following way:
• Federal eRulemaking Portal: http://
information collection described above. General Considerations for Animal www.regulations.gov. Follow the
Copies of the proposed collection of Studies for Medical Devices; Draft instructions for submitting comments.
information can be obtained and Guidance for Industry and Food and Comments submitted electronically,
comments may be forwarded by writing Drug Administration Staff; Availability including attachments, to http://
to the Administration for Children and www.regulations.gov will be posted to
Families, Office of Planning, Research AGENCY: Food and Drug Administration,
the docket unchanged. Because your
and Evaluation, 370 L’Enfant HHS.
comment will be made public, you are
Promenade, SW., Washington, DC ACTION: Notice. solely responsible for ensuring that your
20447, Attn: ACF Reports Clearance comment does not include any
SUMMARY: The Food and Drug
Officer. Email address: infocollection@ confidential information that you or a
Administration (FDA or Agency) is
acf.hhs.gov. All requests should be third party may not wish to be posted,
announcing the availability of the draft
identified by the title of the information such as medical information, your or
guidance entitled ‘‘General
collection. Considerations for Animal Studies for anyone else’s Social Security number, or
The Department specifically requests Medical Devices.’’ FDA has developed confidential business information, such
comments on: (a) Whether the proposed this guidance document to assist as a manufacturing process. Please note
collection of information is necessary industry in designing evaluation that if you include your name, contact
for the proper performance of the strategies for, and reporting the results information, or other information that
of, animal studies for medical devices. identifies you in the body of your
functions of the agency, including
The intent of this draft guidance is to comments, that information will be
whether the information shall have
provide a reference of best practices for posted on http://www.regulations.gov.
practical utility; (b) the accuracy of the • If you want to submit a comment
agency’s estimate of the burden of the the approach to, and conduct of, animal
with confidential information that you
proposed collection of information; (c) studies, and the presentation of animal
do not wish to be made available to the
the quality, utility, and clarity of the study data intended to demonstrate that
public, submit the comment as a
information to be collected; and (d) the device under study is sufficiently
written/paper submission and in the
ways to minimize the burden of the safe for early human experience (e.g., to
manner detailed (see ‘‘Written/Paper
collection of information on support an investigational device
Submissions’’ and ‘‘Instructions’’).
respondents, including through the use exemption (IDE) application) or to
demonstrate device safety in support of Written/Paper Submissions
of automated collection techniques or
a marketing application, while Submit written/paper submissions as
other forms of information technology.
incorporating modern animal care and follows:
Consideration will be given to use strategies. This draft guidance is not
comments and suggestions submitted • Mail/Hand delivery/Courier (for
final nor is it in effect at this time. written/paper submissions): Division of
within 60 days of this publication.
DATES: Although you can comment on Dockets Management (HFA–305), Food
Robert Sargis, any guidance at any time (see 21 CFR and Drug Administration, 5630 Fishers
tkelley on DSK3SPTVN1PROD with NOTICES
Reports Clearance Officer. 10.115(g)(5)), to ensure that the Agency Lane, Rm. 1061, Rockville, MD 20852.
[FR Doc. 2015–25998 Filed 10–13–15; 8:45 am] considers your comment on this draft • For written/paper comments
guidance before it begins work on the submitted to the Division of Dockets
BILLING CODE 4184–01–P
final version of the guidance, submit Management, FDA will post your
either electronic or written comments comment, as well as any attachments,
on the draft guidance by January 12, except for information submitted,
2016. marked and identified, as confidential,
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![61822 Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
Dated: October 7, 2015. do not wish to be made available to the regulatoryinformation/dockets/
Leslie Kux, public, submit the comment as a default.htm.
Associate Commissioner for Policy. written/paper submission and in the Docket: For access to the docket to
[FR Doc. 2015–26055 Filed 10–13–15; 8:45 am] manner detailed (see ‘‘Written/Paper read background documents or the
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://
Written/Paper Submissions
www.regulations.gov and insert the
DEPARTMENT OF HEALTH AND Submit written/paper submissions as docket number, found in brackets in the
HUMAN SERVICES follows: heading of this document, into the
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
Food and Drug Administration written/paper submissions): Division of and/or go to the Division of Dockets
Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
[Docket No. FDA–2010–N–0128] and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
Prescription Drug User Fee Act; Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
• For written/paper comments
Reopening of Comment Period Graham Thompson, Center for Drug
submitted to the Division of Dockets
Management, FDA will post your Evaluation and Research, Food and
AGENCY: Food and Drug Administration,
HHS. comment, as well as any attachments, Drug Administration, 10903 New
except for information submitted, Hampshire Ave., Bldg. 51, Rm. 1146,
ACTION: Notice; reopening of comment Silver Spring, MD 20993–0002, 301–
period. marked and identified, as confidential,
if submitted as detailed in 796–5003.
SUMMARY: The Food and Drug ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the
Administration (FDA) is reopening until Instructions: All submissions received Federal Register of May 13, 2015, FDA
April 29, 2016, the comment period for must include the Docket No. FDA– published a notice of public meeting
the notice of public meeting that 2010–N–0128 for ‘‘Prescription Drug with a 30-day comment period
appeared in the Federal Register of May User Fee Act; Reopening of Comment following the public meeting and
13, 2015 (80 FR 27323). In the notice of Period.’’ Received comments will be invited comments as the Agency began
public meeting, FDA invited public placed in the docket and, except for the process to reauthorize PDUFA in
comment as the Agency begins the those submitted as ‘‘Confidential FYs 2018 to 2022.
process to reauthorize the Prescription Submissions,’’ publicly viewable at FDA is reopening the comment period
Drug User Fee Act (PDUFA) in fiscal http://www.regulations.gov or at the until April 29, 2016. The Agency
years (FYs) 2018 to 2022. The Agency is Division of Dockets Management believes that reopening the comment
taking this action to allow interested between 9 a.m. and 4 p.m., Monday period for the notice of public meeting
persons additional time to submit through Friday. will allow adequate time for interested
comments. • Confidential Submissions—To persons to submit comments.
DATES: FDA is reopening the comment submit a comment with confidential Dated: October 7, 2015.
period on the notice of public meeting information that you do not wish to be Leslie Kux,
published May 13, 2015 (80 FR 27323). made publicly available, submit your
Associate Commissioner for Policy.
Submit either electronic or written comments only as a written/paper
[FR Doc. 2015–26052 Filed 10–13–15; 8:45 am]
comments by April 29, 2016. submission. You should submit two
copies total. One copy will include the BILLING CODE 4164–01–P
ADDRESSES: You may submit comments
as follows: information you claim to be confidential
with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS DEPARTMENT OF HEALTH AND
CONFIDENTIAL INFORMATION’’. The HUMAN SERVICES
Submit electronic comments in the
following way: Agency will review this copy, including Food and Drug Administration
• Federal eRulemaking Portal: http:// the claimed confidential information, in
www.regulations.gov. Follow the its consideration of comments. The [Docket No. FDA–2015–D–3399]
instructions for submitting comments. second copy, which will have the
claimed confidential information Recommendations for Microbial
Comments submitted electronically,
redacted/blacked out, will be available Vectors Used for Gene Therapy; Draft
including attachments, to http://
for public viewing and posted on http:// Guidance for Industry; Availability
www.regulations.gov will be posted to
the docket unchanged. Because your www.regulations.gov. Submit both AGENCY: Food and Drug Administration,
comment will be made public, you are copies to the Division of Dockets HHS.
solely responsible for ensuring that your Management. If you do not wish your ACTION: Notice.
comment does not include any name and contact information to be
confidential information that you or a made publicly available, you can SUMMARY: The Food and Drug
third party may not wish to be posted, provide this information on the cover Administration (FDA or Agency) is
such as medical information, your or sheet and not in the body of your announcing the availability of a draft
anyone else’s Social Security number, or comments and you must identify this document entitled ‘‘Recommendations
confidential business information, such information as ‘‘confidential.’’ Any for Microbial Vectors Used for Gene
as a manufacturing process. Please note information marked as ‘‘confidential’’ Therapy; Draft Guidance for Industry.’’
tkelley on DSK3SPTVN1PROD with NOTICES
that if you include your name, contact will not be disclosed except in The draft guidance provides
information, or other information that accordance with 21 CFR 10.20 and other investigational new drug application
identifies you in the body of your applicable disclosure law. For more (IND) sponsors, with recommendations
comments, that information will be information about FDA’s posting of concerning IND submissions for
posted on http://www.regulations.gov. comments to public dockets, see 80 FR microbial vectors used for gene therapy
• If you want to submit a comment 56469, September 18, 2015, or access (MVGTs) in early-phase clinical trials.
with confidential information that you the information at: http://www.fda.gov/ MVGTs meet the regulatory definition of
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Document Created: 2018-02-27 08:50:19
Document Modified: 2018-02-27 08:50:19
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 12, 2016. | |
| Contact | Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. | |
| FR Citation | 80 FR 61820 |
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