80 FR 66011 - Product Development Under the Animal Rule; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 208 (October 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 208 (October 28, 2015)
| Page Range | 66011-66013 | |
| FR Document | 2015-27361 |
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)] [Notices] [Pages 66011-66013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27361] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0007] Product Development Under the Animal Rule; Guidance for Industry; 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 a guidance for industry entitled ``Product Development Under the Animal Rule.'' When human efficacy studies are not ethical and field trials are not feasible, FDA may rely on adequate and well-controlled animal efficacy studies to support approval of a drug or licensure of a biological product under the Animal Rule. This guidance finalizes the 2014 revised draft guidance for industry ``Product Development Under the Animal Rule.'' It is intended to help potential stakeholders (industry, academia, and government) understand FDA's expectations for product development under the Animal Rule. [[Page 66012]] DATES: Submit either electronic or written comments on Agency guidances at any time. 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, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2009-D-0007 for ``Product Development Under the Animal Rule; Guidance for Industry; Availability.'' 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. Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. This guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Rosemary Roberts, Counter-Terrorism and Emergency Coordination Staff, Office of the Center Director, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, Rm. 2155, Silver Spring, MD 20993-0002, 301-796-2210; or Cynthia Kelley, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7204, Silver Spring, MD 20993-0002, 240-402-8089. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Product Development Under the Animal Rule.'' In the Federal Register of June 3, 2014 (79 FR 31950), FDA announced the availability of a revised draft guidance for industry entitled ``Product Development Under the Animal Rule,'' intended to help potential stakeholders understand FDA's expectations for product development under the Animal Rule (see 21 CFR 314.600 through 314.650 for drugs and 21 CFR 601.90 through 601.95 for biological products). The 2014 revised draft guidance replaced the 2009 draft guidance for industry entitled ``Animal Models--Essential Elements to Address Efficacy Under the Animal Rule'' (74 FR 3610) and addressed a broader scope of issues for products developed under the Animal Rule. The comment period for the revised draft guidance closed on August 4, 2014. We reviewed all comments received and considered them in finalizing the revised draft guidance. This guidance finalizes the revised draft guidance issued on June 3, 2014.\1\ --------------------------------------------------------------------------- \1\ Adequate and well-controlled animal efficacy studies are required under the Animal Rule. As a policy, FDA is committed to the exploration of non-animal testing methods. --------------------------------------------------------------------------- This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on product development under the Animal Rule. 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. II. Paperwork Reduction Act This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 [[Page 66013]] (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312 (investigational new drug applications) has been approved under OMB control number 0910-0014. The collection of information in 21 CFR part 314 (new drug applications) has been approved under OMB control number 0910-0001. The collection of information resulting from special protocol assessments has been approved under OMB control number 0910- 0470. The collection of information resulting from formal meetings between applicants and FDA has been approved under OMB control number 0910-0429. The collection of information resulting from good laboratory practices has been approved under OMB control number 0910-0119. The collection of information resulting from current good manufacturing practices has been approved under OMB control number 0910-0139. III. Electronic Access Persons with access to the Internet may obtain the document athttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/RegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: October 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27361 Filed 10-27-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices 66011
investigators and sponsors. FDA the study, records of shipment and sponsors’ recordkeeping and reporting
requires this information for tracking disposition, signed investigator burden is reduced. Pertinent records on
and oversight purposes. Investigators agreements, adverse device effects the study must be maintained by both
are required to maintain records, information, and, for a nonsignificant parties, and reports are made to
including correspondence and reports risk device study, an explanation of the sponsors and institutional review
concerning the study, records of receipt, nonsignificant risk determination, boards (IRBs). Reports are made to FDA
use or disposition of devices, records of records of device name and intended only in certain circumstances, e.g.,
each subject’s case history and exposure use, study objectives, investigator recall of the device, the occurrence of
to the device, informed consent information, investigational review unanticipated adverse effects, and as a
documentation, study protocol, and board information, and statement on the consequence of certain IRB actions. The
documentation of any deviation from extent that good manufacturing estimate of the burden is based on the
the protocol. Sponsors are required to practices will be followed. number of IDEs received in recent years.
maintain records including For a nonsignificant risk device FDA estimates the burden of this
correspondence and reports concerning investigation, the investigators’ and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Waivers—812.10 .................................................................. 1 1 1 1 1
IDE Application—812.20, 812.25, and 812.27 .................... 356 1 356 80 28,480
Supplements—812.35 and 812.150 .................................... 356 12 4,272 6 25,632
Treatment IDE Applications—812.36(c) .............................. 1 1 1 120 120
Treatment IDE Reporting—812.36(f) ................................... 1 1 1 20 20
Total .............................................................................. ........................ ........................ ........................ ........................ 54,253
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total Hours
recordkeepers records
recordkeeper recordkeeping
Original—812.140 ................................................................ 356 1 356 10 3,560
Supplemental—812.140 ....................................................... 356 12 4,272 1 4,272
Nonsignificant—812.140 ...................................................... 356 1 356 6 2,136
Total .............................................................................. ........................ ........................ ........................ ........................ 9,968
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
Reports for Nonsignificant Risk Studies—812.150 ............. 1 1 1 6 6
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 22, 2015. DEPARTMENT OF HEALTH AND guidance for industry entitled ‘‘Product
Leslie Kux, HUMAN SERVICES Development Under the Animal Rule.’’
Associate Commissioner for Policy. When human efficacy studies are not
Food and Drug Administration ethical and field trials are not feasible,
[FR Doc. 2015–27420 Filed 10–27–15; 8:45 am]
BILLING CODE 4164–01–P [Docket No. FDA–2009–D–0007] FDA may rely on adequate and well-
controlled animal efficacy studies to
Product Development Under the support approval of a drug or licensure
Animal Rule; Guidance for Industry; of a biological product under the
Availability Animal Rule. This guidance finalizes
mstockstill on DSK4VPTVN1PROD with NOTICES
the 2014 revised draft guidance for
AGENCY: Food and Drug Administration,
industry ‘‘Product Development Under
HHS.
the Animal Rule.’’ It is intended to help
ACTION: Notice of availability. potential stakeholders (industry,
SUMMARY: The Food and Drug academia, and government) understand
Administration (FDA or Agency) is FDA’s expectations for product
announcing the availability of a development under the Animal Rule.
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![Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices 66013
(44 U.S.C. 3501–3520). The collection of of reformulated drug products or Management, FDA will post your
information in 21 CFR part 312 products being used by an alternate comment, as well as any attachments,
(investigational new drug applications) route. It is intended for use by interested except for information submitted,
has been approved under OMB control individuals in industry and reviewers marked and identified, as confidential,
number 0910–0014. The collection of within the Center for Drug Evaluation if submitted as detailed in
information in 21 CFR part 314 (new and Research (CDER). The goals of this ‘‘Instructions’’.
drug applications) has been approved guidance are to foster and expedite the Instructions: All submissions received
under OMB control number 0910–0001. development of reformulated drug must include the Docket No. FDA–
The collection of information resulting products or the use of previously 2008–D–0142 for ‘‘Nonclinical Safety
from special protocol assessments has approved drugs by alternate routes, Evaluation of Reformulated Drug
been approved under OMB control communicate to industry current CDER Products and Products Intended for
number 0910–0470. The collection of thoughts pertaining to safety data Administration by an Alternate Route;
information resulting from formal needed to support these drug products, Guidance for Industry and Review
meetings between applicants and FDA and increase uniformity within CDER Staff.’’ Received comments will be
has been approved under OMB control on expectations for the nonclinical placed in the docket and, except for
number 0910–0429. The collection of development of reformulated drug those submitted as ‘‘Confidential
information resulting from good products or products being used by an Submissions,’’ publicly viewable at
laboratory practices has been approved alternate route. This guidance finalizes http://www.regulations.gov or at the
under OMB control number 0910–0119. the draft guidance of the same name Division of Dockets Management
The collection of information resulting published on March 7, 2008. between 9 a.m. and 4 p.m., Monday
from current good manufacturing through Friday.
DATES: Submit either electronic or
practices has been approved under OMB • Confidential Submissions—To
written comments on Agency guidances submit a comment with confidential
control number 0910–0139. at any time. information that you do not wish to be
III. Electronic Access ADDRESSES: You may submit comments made publicly available, submit your
Persons with access to the Internet as follows: comments only as a written/paper
may obtain the document athttp://www. Electronic Submissions submission. You should submit two
fda.gov/Drugs/GuidanceCompliance copies total. One copy will include the
RegulatoryInformation/Guidances/ Submit electronic comments in the information you claim to be confidential
default.htm, http://www.fda.gov/ following way: with a heading or cover note that states
BiologicsBloodVaccines/Guidance • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
ComplianceRegulatoryInformation/ www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
Guidances/default.htm, http://www.fda. instructions for submitting comments. Agency will review this copy, including
gov/RegulatoryInformation/Guidances/ Comments submitted electronically, the claimed confidential information, in
default.htm, or http:// including attachments, to http:// its consideration of comments. The
www.regulations.gov. www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Dated: October 22, 2015.
comment will be made public, you are redacted/blacked out, will be available
Leslie Kux,
solely responsible for ensuring that your for public viewing and posted on http://
Associate Commissioner for Policy. comment does not include any www.regulations.gov. Submit both
[FR Doc. 2015–27361 Filed 10–27–15; 8:45 am] confidential information that you or a copies to the Division of Dockets
BILLING CODE 4164–01–P third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
anyone else’s Social Security number, or made publicly available, you can
DEPARTMENT OF HEALTH AND confidential business information, such provide this information on the cover
HUMAN SERVICES as a manufacturing process. Please note sheet and not in the body of your
Food and Drug Administration that if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential’’. Any
[Docket No. FDA–2008–D–0142] identifies you in the body of your information marked as ‘‘confidential’’
comments, that information will be will not be disclosed except in
Nonclinical Safety Evaluation of posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Reformulated Drug Products and • If you want to submit a comment applicable disclosure law. For more
Products Intended for Administration with confidential information that you information about FDA’s posting of
by an Alternate Route; Guidance for do not wish to be made available to the comments to public dockets, see 80 FR
Industry and Review Staff; Availability public, submit the comment as a 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, written/paper submission and in the the information at: http://www.fda.gov/
HHS. manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). default.htm.
Docket: For access to the docket to
SUMMARY: The Food and Drug Written/Paper Submissions read background documents or the
Administration (FDA or Agency) is Submit written/paper submissions as electronic and written/paper comments
mstockstill on DSK4VPTVN1PROD with NOTICES
announcing the availability of a follows: received, go to http://
guidance for industry and review staff • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
entitled ‘‘Nonclinical Safety Evaluation written/paper submissions): Division of docket number, found in brackets in the
of Reformulated Drug Products and Dockets Management (HFA–305), Food heading of this document, into the
Products Intended for Administration and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
by an Alternate Route.’’ The guidance Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
provides recommendations concerning • For written/paper comments Management, 5630 Fishers Lane, Rm.
the evaluation of the nonclinical safety submitted to the Division of Dockets 1061, Rockville, MD 20852.
VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\28OCN1.SGM 28OCN1](https://thefederalregister.org/doc/80_FR_66219/page/3.svg)
Document Created: 2018-02-27 08:58:17
Document Modified: 2018-02-27 08:58:17
| 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 Agency guidances at any time. | |
| Contact | Rosemary Roberts, Counter-Terrorism and Emergency Coordination Staff, Office of the Center Director, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, Rm. 2155, Silver Spring, MD 20993-0002, 301-796-2210; or Cynthia Kelley, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7204, Silver Spring, MD 20993-0002, 240-402-8089. | |
| FR Citation | 80 FR 66011 |
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